Accepted Manuscript Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery (NOTES): a series of 137 patients Chyi-Long Lee, MD, PhD Kai-Yun Wu, MD Hsuan Su, MD Pei-Ju Wu, MD Chien-Min Han, MD Chih-Feng Yen, MD. PII:
S1553-4650(14)00206-4
DOI:
10.1016/j.jmig.2014.03.011
Reference:
JMIG 2277
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 14 December 2013 Revised Date:
13 March 2014
Accepted Date: 13 March 2014
Please cite this article as: Lee CL, Wu KY, Su H, Wu PJ, Han CM, Yen CF, Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery (NOTES): a series of 137 patients, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/j.jmig.2014.03.011. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Hysterectomy
by
Transvaginal
Natural
Orifice
Transluminal
2
Endoscopic Surgery (NOTES): a series of 137 patients
3
Chyi-Long Lee, MD, PhD; Kai-Yun Wu, MD; Hsuan Su, MD; Pei-Ju Wu, MD,
4
Chien-Min Han, MD, Chih-Feng Yen, MD.
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*The first 2 authors (Drs Lee and Wu) contributed equally to the study.
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From the Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital at
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Linkou and University (Drs Lee, K-Y Wu, Su, Han, and Yen); the Graduate Institute of
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Clinical Medical Sciences, Chang Gung University College of Medicine, Tao-Yuan (Dr Yen);
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and the Department of Obstetrics and Gynecology, Chung Shan Medical University
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Hospital, Taichung (Dr. P-J Wu), Taiwan, Republic of China.
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Corresponding author: Chih-Feng Yen, MD, Department of Obstetrics and
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Gynecology, Chang Gung Memorial Hospital at Linkou, 5, Fu-Hsin St, Kwei-Shan,
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Tao-Yuan, Taiwan 33305. Tel: +886-3-1200, E-mail: [email protected]
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Author contributions: C.-L.L., K.-Y.W., H.S. and C.-F.Y. conceived and designed the
15
study; K.-Y.W., H.S., P.-J. W. and C.-M. H. acquired the data; C.-F. Y. analyzed and
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interpreted the data; K.-Y.W. and C.-F. Y. drafted the manuscript; C.-L.L. and C.-F.Y.
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reviewed the data and revised the manuscript critically for scientific and intellectual
18
content. All authors approved the final version for submission.
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Funding: This study was partially supported by Chang Gung Memorial Hospital
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research grants CMRPG370151 and CMRPG381361. Dr C.-F. Yen is the principal
21
investigator.
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Financial Disclosure: All authors have no conflict of interest to be declared.
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Presentation: This study was presented in part at the 42nd Global Congress of
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Minimally Invasive Gynecology (Annual Meeting of the AAGL), Washington DC,
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November 10-14, 2013.
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Running title: Hysterectomy by Purely Transvaginal NOTES
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Précis
29 Transvaginal natural-orifice transluminal laparoscopic surgery (NOTES) is a safe
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and feasible technique to undergo hysterectomy.
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ABSTRACT
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Study Objective: To evaluate the feasibility and safety of hysterectomy in benign
35
disease with transvaginal natural orifice transluminal endoscopic surgery (NOTES).
36
Design: Prospective observational study.
37
Setting: Tertiary referral medical center.
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Patients: From May 2010 to August 2011, consecutive patients who were scheduled
39
for laparoscopic hysterectomy and without virginity or the suspicion of pelvic
40
inflammation, or cul-de-sac obliteration were included.
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Intervention: Total hysterectomy with transvaginal NOTES.
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Measurements and Main Results: All included patients were 137, with mean age
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46.0±0.4 years and BMI 24.7±0.4 kg/m2 ([±SEM]), respectively, and transvaginal
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NOTES was successfully completed in 130 (94.9%) patients. 15 patients underwent
45
concurrent adhesiolysis and 17 with adnexal procedures. Mean uterine weight was
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450.0±24.1 gm, where 45 (34.6%) patients had weights >500gm, and 7 (5.4%) patients
47
>1000gm. Mean operative time was 88.2±4.1 minutes, with mean blood loss
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257.7±23.9 mL. Two patients encountered intraoperative hemorrhage or unintended
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cystotomy, another 5 with failure of transvaginal colpotomy due to a very narrow
50
vagina, cul-de-sac obliateration by bowel adhesions, or mass obstruction, and all
51
these 7 (5.1%) patients were successfully dealt with transabdominal laparoscopy.
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Five (3.6%) patients experienced postoperative urinary retention or febrile morbidity,
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and recovered uneventfully with conservative treatments.
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Conclusion: Transvaginal NOTES is feasible to perform hysterectomy and can
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undergo procedures hardly completed in conventional vaginal surgery, given that
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posterior colpotomy is achievable. This procedure was not impeded by the
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voluminous size of uterus, and was advantaged by the absolution of any abdominal
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incision.
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Keywords: Hysterectomy, laparoscopy, vaginal surgery, natural orifice transluminal
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endoscopic surgery (NOTES).
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Introduction Natural orifice transluminal endoscopic surgery (NOTES) is a novel concept
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of using the natural orifices of human bodies to be the surgical channels and avoid
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visible abdominal scars [1]. Different techniques had been developed such as
67
transcolonic access and per-oral transgastric or transesophageal accesses, however,
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transvaginal access is the most frequently used approach for NOTES [2].
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The techniques of transvaginal endoscopy have been reported in gynecology
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[3-6], and termed ‘culdoscopy’ or ‘ventroscopy’ [7] in the past. With the criticisms of
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restricted visualization and limited operative capabilities, its application diminished
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after the popularity of abdominal laparoscopy in the 1970s. Transvaginal
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hydrolaparoscopy (THL) developed later [8-10], this technique was mainly restricted
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to the diagnostic evaluation of infertility.
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Though conventional vaginal surgeries has been a gynecologic expertise in
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daily practice, some procedures can only be achieved with palpation in some
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conditions, such as doing vaginal hysterectomy while the uterus is large or without
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descensus, or performing concomitant adnexal surgeries. We recently developed a
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technique of transvaginal NOTES using the wound-retractor-and-glove system [1]
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and demonstrated that transvaginal NOTES can perform not only adnexal
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procedures [11, 12], but hysterectomies [13] as well. In our preliminary experience,
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transvaginal NOTES combines the features of vaginal surgery and the new
83
techniques of single-port laparoscopic surgery, which widened the capability and
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achievability of conventional vaginal surgery in a variety of circumstances, and
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yielded a favorable result of scarless abdomen [13]. However, we also noted that
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transvaginal procedures are inherently quite different from that of transabdominal
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approaches. The purpose of this study was to evaluate the feasibility and to explore
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the possible limitations of hysterectomy performed with transvaginal NOTES in the
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daily practice for benign gynecologic disease.
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Materials and Methods This study was reviewed and approved by the Human Investigation Review
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Board of Chang Gung Memorial Hospital. All patients who underwent surgical
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management gave their written informed consents. Experienced gynecologic
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endoscopists performed all surgeries.
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96 Patients
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Patients scheduled for laparoscopic hysterectomy from May 2010 to August
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2011 in Chang Gung Memorial Hospital were prospectively included to perform
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transvaginal NOTES. Conditions such as obesity (body mass index >30 kg/m2),
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those who never had vaginal deliveries, those who needed concomitant adnexal
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surgeries, and those with a history of previous cesarean deliveries or abdominal
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surgeries were not considered contraindications. However, patients of virginity,
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suspected with severe pelvic adhesions from prior abdominal surgeries,
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tubo-ovarian abscesses, or endometriosis were excluded.
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Surgical techniques
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Previously published surgical techniques [1, 13] are described in brief as the
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following: Under general anesthesia with endotracheal intubation, patients were
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placed in Trendelenburg position with legs bandaged and supported in the stirrups.
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One 12-French Foley catheter was indwelled. The operation started as in
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conventional vaginal surgery with a circumcision of vaginal wall around the cervix
113
and creating a 3-cm posterior colpotomy through the posterior fornix of the vagina.
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Then the uterosacral ligaments were dissected, and the uterine vessels sealed and cut
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up to the level of isthmus with either suture-ligation or LigaSure system (Valleylab,
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Boulder, CO) designed for laparotomy. With the exception of several initial patients,
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anterior colpotomy was achieved first with the complete dissection of peritoneum
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reflection at bladder base.
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The vaginal port was then established by inserting the inner rim of a small
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Alexis wound retractor (Applied Medical Resources Corp., Rancho Santa Margarita,
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CA) around the cervix and fixing from behind the colpotomy wound (Fig 1A), and
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the outer rim of the wound retractor outside the vagina was draped with the
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disposable surgical glove in which 3 of the fingers were fixed with 10-mm or 5-mm
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cannulas (Fig 1B). We used a 5-mm, 30-degree endoscope (KARL STORZ GmbH &
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Co. KG, Tuttlingen Germany) or a 10-mm conventional endoscope as visual media, a
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laparoscopic single tooth tenaculum to manipulate the uterus, and a 5-mm LigaSure
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system (Valleylab, Boulder, CO) designed for laparoscopy as energy source. All
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other necessary instruments are the ordinary straight ones as are used in the
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conventional laparoscopy.
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Transvaginal NOTES then began after adequate pneumoperitoneum. For the
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several initial patients, the vaginal ports were established prior to the opening of the
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peritoneum reflection at bladder base during the anterior colpotomy, so that the
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peritoneum could be dissected first under endoscopic guidance. The remaining
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structures going upward from the isthmic level, including broad ligaments, round
135
ligaments, ovarian ligaments and Fallopian tubes, were then sealed and cut with
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LigaSure to complete the hysterectomy (Fig 2 A-D). If any adnexal lesions were
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found, enucleation, salpingectomy or salpingo-oophorectomy was performed
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whenever appropriate [11]. After taking out the glove with cannulas, the uterus was
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removed with morcellation through the vagina under the protection of a wound
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retractor.
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Then, the NOTES resumed by readapting the surgical glove again to ensure
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hemostasis and to overlook the whole pelvis and abdominal cavity. Finally, the
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surgery ended after closure of the vaginal cuff and a routine checkup of cystoscopy.
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144 Treatment protocol
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We gave prophylactic antibiotics preoperatively with a single-dose of
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parenteral cefazolin, and postoperatively with cefazolin and gentamicin for 24 hours.
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The Foley catheter was indwelled overnight. According to the regulations of our
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national insurance, patients could not be discharged until an afebrile status for at
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least 24 hours, good wound healing, full recovery of urinary and gastrointestinal
151
functions and without evidence of surgical complications. Vaginal intercourse was
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prohibited within 2 months after operation. Patients returned to our outpatient
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clinic one week and one month after the surgery for check-up. Three months later,
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patients were evaluated for general wellbeing and sexual function, including
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dyspareunia or post-coital bleeding.
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Data analysis
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Continuous variables such as age, body mass index (BMI) and uterine weight
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are presented as mean±SEM, whereas discrete variables such as parity are presented
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as median value and range. Descriptive statistics were performed using SPSS for
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Windows, release 17.0.0/2008 (IBM-SPSS, Inc., Chicago, IL).
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Results From May 2010 to August 2011, we enrolled a total of 137 patients who had
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preoperative benign diseases that required hysterectomy. Their demographics are
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presented in Table 1. The study population was aged 46.0±0.4 years, the median
166
parity 2, and the mean BMI 24.7±0.4 kg/m2. Eight (5.8%) of the patients were
167
nulliparous, in addition to 26 (19.0%) patients without a history of vaginal deliveries.
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50 (36.5%) patients had previous abdominal surgeries, including 38 (27.7%) cesarean
169
deliveries, 7 (5.1%) laparotomies, and 5 (3.6%) laparoscopies.
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Hysterectomies with pure transvaginal NOTES was successfully completed in
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130 (94.9%) of the 137 patients, while 7 (5.1%) patients were converted to
172
conventional laparoscopy. Among the 130 patients, concomitant pelvic surgeries
173
including 3 enucleations, 6 salpingectomies, 8 salpingo-oophorectomies, and 15
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extensive adhesiolysis, were also carried out successfully purely with transvaginal
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NOTES. As presented in Table 2, the mean uterine weight in this series was
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450.0±24.1 gm, in which 39 (30%) patients had weights between 300gm and 500 gm,
177
and 45 (34.6%) patients had weights >500gm. 7 (5.4%) patients had uterine weights
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>1000gm, up to an extreme value of 1630gm. The mean operation time was 88.2±4.1
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minutes. Mean blood loss was 257.7±23.9 mL, mean decrease of hemoglobin between
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pre-operation and the first post-operation day was 1.2±0.1 g/dL, and 10 (7.7%)
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patients received blood transfusions intraoperatively. Mean post-operative hospital
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stay was 2.8±0.07 days. The final pathologic reports were leiomyomas and/or
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adenomyosis, with the exception of one patient with endometrial stromal sarcoma
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(Table 2).
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In the current series, there were 2/137 (1.5%) patients with intraoperative
186
complications and 5/137 (3.6%) patients with a failed attempt of vaginal approach,
187
and all 7 patients were converted to conventional laparoscopy to complete the
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surgeries, as presented in Table 3. The conversion rate was 5.1% (7/137) on the
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intention-to-treat basis. As for the intraoperative complications, one patient had an
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unintended cystotomy at trigone during anterior colpotomy, which was revealed
191
immediately by palpating the Foley balloon through a 1-cm hole of perforation. The
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operation was then shifted to conventional laparoscopy where the bladder
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perforation was repaired with primary sutures and an indwelling Foley catheter for
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7 days. No sequela was noted at the one-month follow up. With another patient, we
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encountered a profound vaginal bleeding from the regurgitation of a very large
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uterus, which obscured the operation field that made the transvaginal approach very
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difficult. Therefore the approach was converted to conventional laparoscopy.
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There were 5 patients with a failed attempt from transvaginal NOTES and we
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managed with conversion to transabdominal laparoscopy. One nullipara had a very
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narrow vagina that inhibited the downward traction of the large uterus. Two
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patients had a large uterine myoma at the lower anterior low corpus that obstructed
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the way of anterior colpotomy, and another patient had a large intraligamentous
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uterine myoma at the lower corpus, which also obstructed the way of transvaginal
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colpotomy. The last case had severe endometriosis in the cul-de-sac, which
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developed dense adhesions among the uterosacral ligaments and the rectum that
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obstructed the way of posterior colpotomy.
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We encountered 5/137 (3.6%) patients with postoperative morbidities, as
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listed in Table 4. One patient had a difficulty voiding postoperatively. A Foley
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catheter was indwelled for five days and the voiding function recovered to normal.
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Four patients were complicated with postoperative febrile morbidity. Of the four,
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three presented with severe lower abdominal pain, leukocytosis and elevated
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C-reactive protein one week after discharge and required re-hospitalization for
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antibiotics treatment. All these patients had negative findings in ultrasonorgaphy
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and computed tomography, and recovered uneventfully after empiric antibiotics
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with ceftriaxone and metronidazole for three to seven days. The other febrile patient
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developed a urinary tract infection one week after discharge. She was re-admitted
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for hydration, empiric antibiotics for 3 days, and recovered.
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After a follow-up for up to three months after operation, all patients had good healing of vaginal cuff with normal voiding and sexual functions. All the patients
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completed with pure transvaginal NOTES were highly satisfied with the absolution
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of any incisions on their abdominal wall.
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Discussion The current series proved our concept that hysterectomy performed with
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transvaginal NOTES [13] is feasible for daily practice, with a success rate of almost
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95%. Instead of using an additional abdominal port as the so-called hybrid-NOTES
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[14-16], our method was advantaged by undergoing completely a single-port
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laparoscopy-like technique through purely vaginal approach, and eliminate any
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wound in abdominal wall [17].
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We learned in the current series that transvaginal NOTES can be applied to
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accomplish some difficult procedures in conventional vaginal surgeries, with few
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exceptions. Conventional vaginal hysterectomy could be prohibited by the enlarged
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size of uterus, or the condition of undescensus, or by a restricted vaginal space such
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as in women who never experienced vaginal deliveries. In the current series, the
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mean weight of the uterine specimen was nearly 460 gm, in which 45 (34.6%)
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patients had uterine weight > 500gm and 7 of them >1000gm, so that the size and
236
weight of the uterus did not seem to be a hamper. There were also 8 (5.8%) patients
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of nulliparity and 26 (19.0%) patients never experienced vaginal delivery. However,
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hysterectomies in the current series could generally be completed uneventfully with
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transvaginal NOTES in almost all these situations, therefore the restricted vaginal
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space and uterus without descensus were not contraindications.
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Besides, adhesiolysis and adnexal procedures in conventional vaginal
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surgeries were also very difficult because of the limited accessibility in the restricted
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space. In the current series, 33 of 130 (25.4%) patients were noted with adnexal
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pathologies or pelvic adhesion. As a result, transvaginal NOTES can feasibly
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undergo the concurrent salpingectomy, salpingo-oophorectomy, the adhesiolysis,
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and enucleation of ovarian tumor with suture repair without additional difficulties
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to hysterectomy per se, as was reported in our previous publication [11]. In addition,
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delicate hemostasis was achieved by direct vision with laparoscopy before the
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closure of vaginal wound. Therefore, transvaginal NOTES extended the scope and
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capability of the conventional vaginal surgery.
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In our experience, one advantage of the transvaginal NOTES for hysterectomy
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was with a shorter operating time than the abdominal laparoscopic hysterectomy.
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Obviously we avoided the time of opening and closing the abdominal wound.
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Besides, because the uterus was directly in traction and handled by the operator and
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not the assistant, the communication with the assistant for adjusting the uterine
256
position could be spared, which made the progress of the operation more fluent and
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hence could contribute to the shortening of the operating time.
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Another advantage of the transvaginal NOTES for hysterectomy is its earlier
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blockage of the uterine vessels. Since the uterine arteries were supplied at the level
260
of the isthmus, it would be more accessible from the transvaginal approach, which is
261
beneficial especially in situations with a large uterus. Since in most situations, the
262
uterine myoma or adenomyosis was located at uterine corpus and the cervix
263
remained small, the trial to approach uterine arteries from the abdominal route was
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usually interfered by the voluminous corpus, which sometimes caused more
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bleeding. However, sealing the uterine vessels transvaginally in these situations was
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much easier, and with that being achieved at the beginning of the operation made
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the procedure afterward almost bloodless and efficient. In the current series, we
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found that intraoperative blood loss was less than that of conventional laparoscopic
269
hysterectomy. Further randomized comparative study is needed in the future to
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prove our observation. There were 10 patients in the current series needing transfusion, all with
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uterine weight >500 gm, and 4 of them with uterine weight >1000 gm. Though the
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size of the uterus could be one of the risk factor of transfusion, however, other
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factors such as the existence of pelvic adhesion, the constrictiveness of pubic arch,
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the location and shape of myoma, as well as the abundant and engorged vessels on
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the uterus, etc., could also contribute to increased blood loss. It is hard to conclude a
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general rule of decreasing intraoperative bleeding in these different situations, but
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the increase of surgeons' experience in blocking the vessels seemed improving the
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results. In further analysis of the current series, 4 patients of the transfusion were
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within the first 10 cases, another 2 were within the subsequent 20 cases, and the
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other 4 scattered in the later 100 cases. This phenomenon may be a support of the
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existence of "learning curve".
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However, patients of conversion and transfusion in the current study were
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different. Only 2 of the 7 patients converted to conventional laparoscopy had
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transfusion, as presented in Table 3, in which only one for the reason of hemorrhage.
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That is a case we failured to seal the multiple engorged vessels in a patient with
287
voluminous uterus. Failure to effectively seal these vessels would cause a profound
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bleeding from the engorged vessels as well as the regurgitation from the large uterus.
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This in turn resulted in a large accumulation of blood in the transvaginal port and
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blurred the vision of transvaginal laparoscopy, which induced a vicious cycle of
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longer operating time and more blood loss. In this situation, the surgery would
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inevitably be converted to the transabdominal approach. We found that the failure of transvaginal NOTES almost arose from the
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impedance of the transvaginal colpotomy in some way, if not from the
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intraoperative complications. In the current series, one patient had a very narrow
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vagina, which made the transvaginal operation nearly impossible. Another patient
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had bowel adhesions in the cul-de-sac, which was impedance to posterior colpotomy,
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and necessitated the conversion to transabdominal laparoscopy. Two other patients,
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each with a large uterine myoma at the lower anterior corpus, had a downward
300
traction of the uterus that simultaneously obstructed the way of anterior cul-de-sac
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impeded the way of anterior colpotomy. In these situations, transabdominal
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laparoscopy was much safer and easier than the transvaginal NOTES.
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Regarding the follow-up of postoperative patients, we found pelvic infection
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in 4/130 (3.1%) patients occurring on the average of 10th day after operation, and all
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these patients were treated recovered uneventfully with parenteral antibiotics. The
306
vagina has been criticized for its lack of asepticism [18, 19], and as these incidences
307
usually happened within the first 20 cases of different surgeons, therefore we
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hypothesized that the postoperative infections could have possibly arisen from the
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unskilled techniques of colpotomy or incomplete hemostasis. This issue warrants
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further investigation while we gain more experience.
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Dyspareunia and sexual abstinence are the other two concerns. However,
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these concerns were universal for all patients undergoing vaginal surgery with
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vaginal cuff sutures, and not specific for NOTES. In the present series, sexual
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abstinence is routinely recommended for 6 to 8 weeks in our practice for
315
transvaginal NOTES, so no patients in our series had problems with dyspareunia or
316
post-coital bleeding at three-month follow up. In conclusion, hysterectomy is feasible to be performed with transvaginal
318
NOTES. Though there were a few complications in this series, but all were resolved
319
with abdominal conventional laparoscopy uneventfully. The advantages of
320
transvaginal NOTES we learned in the current series are that we always can see
321
clearly under the visual guidance of laparoscope and operate precisely by the handle
322
of endoscopic instruments, in comparisons with that some procedures in the
323
conventional vaginal surgeries can only be achieved with palpation in some
324
conditions. It appears that the only impeding factor of transvaginal NOTES is the
325
obstruction of cul-de-sac to avoid the performance of transvaginal posterior
326
colpotomy, however, once this step was successfully done, the size of the specimen
327
would no more be the impeding factors of the operation process. We also found that
328
performing hysterectomy with transvaginal NOTES was generally beneficial with a
329
short operating time and high patient satisfaction as in the conventional vaginal
330
surgery due to the absence of any abdominal wound.
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Therefore we suggest that transvaginal NOTES is an ideal approach for
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hysterectomy in almost all conditions given that transvaginal colpotomy can be
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achieved. Further comparative studies or even randomized controlled trials should
334
be carried out to confirm its advantages and significance in clinical practice.
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Acknowledgements: We thank Lulu Huang, MD for her assistance in editing the manuscript.
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Disclosure Statement: Drs CY Lee, KY Wu, H Su, PJ Wu, CM Han and CF Yen report no
338
conflict of interest. This study was supported partially by Chang Gung Memorial Hospital
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research grants CMRPG370151 and CMRPG381361. Dr C.-F. Yen is the principal investigator.
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References
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1.
Lee CL, Wu KY, Su H, Wu PJ, Han CM, Yen CF. Natural Orifice Transluminal Endoscopic Surgery (NOTES) in Gynecology. Gynecol Minim Invasive Ther. 2012
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Nov;1(1 ):23-6, http://www.e-gmit.com/article/S2213-3070(12)00008-1. 2.
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in humans since white paper. World J Gastroenterol. 2011 Apr 7;17(13):1655-65. 3.
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5.
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Ott Dv. Die Beleuchtung der Bauchhohle (Ventroskopie) als Methode bei Vaginaler Coeliotomie. Abl Gynakol. 1902;231:817-23.
8.
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Clyman MJ. A new panculdoscope--diagnostic, photographic, and operative aspects. Obstet Gynecol. 1963 Mar;21:343-8.
357 358
Cheng MC, Khew KS, Chen C, Ratnam SS, Seng KM, Tan WK. Culdoscopic ligation as an outpatient procedure. Am J Obstet Gynecol. 1975 May 1;122(1):109-12.
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Peretz A, Sharf M. Culdoscopy in gynecologic diagnosis. A review of 404 cases of endoscopic examination. Am J Obstet Gynecol. 1961 Sep;82:582-7.
353 354
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May 28;140(4):378-85.
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Decker A. Culdoscopy; its diagnostic value in pelvic disease. J Am Med Assoc. 1949
De Wilde RL. Transvaginal hydrolaparoscopy. J Am Assoc Gynecol Laparosc. [Letter].
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Santos BF, Hungness ES. Natural orifice translumenal endoscopic surgery: progress
2000 Nov;7(4):599-600. 9.
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Darai E, Dessolle L, Lecuru F, Soriano D. Transvaginal hydrolaparoscopy compared
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with laparoscopy for the evaluation of infertile women: a prospective comparative
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blind study. Hum Reprod. 2000 Nov;15(11):2379-82.
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10.
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Moore ML, Cohen M, Liu GY. Experience with 109 cases of transvaginal hydrolaparoscopy. J Am Assoc Gynecol Laparosc. 2003 May;10(2):282-5.
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Lee CL, Wu KY, Su H, Ueng SH, Yen CF. Transvaginal Natural-Orifice Transluminal Endoscopic Surgery (NOTES) in Adnexal Procedures. J Minim Invasive Gynecol. 2012
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Jul;19(4):509-13. 12.
Lee CL, Wu KY, Su H, Yen CF, Ueng SH. Regarding "transvaginal single-port natural orifice transluminal endoscopic surgery". J Minim Invasive Gynecol. [Letter]. 2013
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Jan;20(1):131-2.
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13.
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Su H, Yen CF, Wu KY, Han CM, Lee CL. Hysterectomy via transvaginal natural orifice
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transluminal endoscopic surgery (NOTES): Feasibility of an innovative approach.
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Taiwan J Obstet Gynecol. 2012 Jun;51(2):217-21.
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Moen MD, Noone MB, Elser DM. Natural orifice hysterectomy. Int Urogynecol J
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14.
Pelvic Floor Dysfunct. [Review]. 2008 Sep;19(9):1189-92. 15.
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Lee D, Dillon B, Lemack G, Gomelsky A, Zimmern P. Transvaginal mesh kits-how
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"serious" are the complications and are they reversible? Urology. 2013
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Jan;81(1):43-9.
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16.
Zorron R, Maggioni LC, Pombo L, Oliveira AL, Carvalho GL, Filgueiras M. NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc. 2008
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Feb;22(2):542-7.
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17.
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Hackethal A, Sucke J, Oehmke F, Munstedt K, Padberg W, Tinneberg HR. Establishing transvaginal NOTES for gynecological and surgical indications: benefits, limits, and
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patient experience. Endoscopy. 2010 Oct;42(10):875-8. 18.
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Rattner D, Kalloo A. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. October 2005. Surg Endosc. 2006 Feb;20(2):329-33.
19.
Hazey JW, Narula VK, Renton DB, Reavis KM, Paul CM, Hinshaw KE, et al.
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Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical
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trial. Surg Endosc. 2008 Jan;22(1):16-20.
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Figure Legends
393 Figure 1. Photograph shows how the portal of transvaginal NOTES was established.
395
(A) The small Alexis wound retractor (Applied Medical Resources Corp., Rancho
396
Santa Margarita, CA) was inserted through and fixed against the colpotomy wound;
397
and (B) a disposable glove attached with three cannulas was draped onto the
398
retractor. The insufflating tube was connected to one of the cannulas to establish
399
pneumoperitoneum.
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Figure 2. Intraoperative photographs from a representative patient shows some
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portion of the endoscopic procedures. (A) A laparoscopic tenaculum forceps grasped
403
at the right lower corpus to expose the right ovary; (B) The left ovarian ligament was
404
exposed when the round ligament was partially done by the LigaSure. (C) Selective
405
right salpingectomy can be done with the preservation of ovary. (D) The left
406
tri-pedicle (the tube, ovarian ligament and round ligament) has been separated from
407
the uterus, and hence the uterus could be removed from the colpotomy wound. (Ut:
408
uterus, Ov: ovary, Tu: tube, R: rectum)
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46.0 ± 0.4
Parity (median [interqartile range])
2 [1 – 3]
P=0 (Nulliparous), N (%)
8 (5.8)
P>1
129 (94.2)
With vaginal delivery, N (%)
103 (75.2)
Without vaginal delivery, N (%)
26 (19.0)
BMI (Kg/m2, mean±SEM)
24.7 ± 0.4
Previous abdominal surgery, N (%)
Laparotomy, N (%)
3
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Laparoscopy, N (%)
50 (36.5)
38 (27.7)
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C-section only, N (%)
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Age (years, mean±SEM)
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Table 1. Patients’ characteristics (N=137)
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Table 2. Surgical Outcomes of the 130 patients who completed NOTES (N=130) 88.2±4.1
Estimated blood loss (ml, mean±SEM)
257.7± 23.9
Decrease of hemoglobin (g/dL, mean±SEM)
1.2 ± 0.1
Blood transfusion, N (%)
10 (7.7)
Uterine weight (gm, mean±SEM)
450.0 ± 24.1
Hospital stay (days, mean±SEM))
Enucleation, N (%) Salpingectomy, N (%)
2.8 ± 0.1
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Concomitant surgeries, N (%)
33 (25.4) 3 (2.3) 6 (4.6) 8 (6.2)
Extensive adhesiolysis, N (%)
15 (11.5)
Posterior colporrhaphy
1 (0.7)
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Salpingo-oophorectomy, N (%)
Pathologic report
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Operative time (min, mean±SEM)
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Leiomyoma, N (%)
60 (46.2)
Adenomyosis, N (%)
18 (13.8)
Leiomyoma and adenomyosis, N (%)
51 (39.2)
Endometrial stromal sarcoma, N (%)
1 (0.7)
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C/S BMI (times) (kg/m2)
Op indication
Op time (min)
Cases of intraoperative complications and conversion
1
50
2
0
24.0
Myoma
267
2
49
2
0
21.3
Myoma
116
Admy
Blood loss (mL) 1500 150
Cases of failed attempt from transvaginal NOTES and conversion
3
40
2
2
38.4
4
43
2
0
32.4
5 6
42 45
0 2
0 1
20.0 20.0
7
40
2
2
20.8
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+ 0.3
Uterine weight (gm)
Length Reasons of failure of stay (day)
Y
1400
3
+ 0.1
N
377
7
+ 0.8
Y
711
4
204
100
- 2.5
N
487
2
168 106
300 200
- 0.8 - 1.9
N N
982 172
3 4
161
500
- 2.9
N
220
3
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Myoma Admy Myoma Admy Myoma Myoma Admy Myoma Admy
Hb BT change
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Parity
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Table 3. Patients with intra-operative conversions or complications
Massive vaginal bleeding Bladder perforation
Anterior low corpus myoma Broad ligament myoma Narrow vagina Rectum adherent to uterosacral ligament Anterior low corpus myoma
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Number (% in N=137) 1 (0.7%)
Febrile morbidity, N (%)
4 (2.9%)
Lower abdominal pain, N (%)
3 (2.2%)
Urinary tract infection, N (%)
1 (0.7%)
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Urinary retention, N (%)
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http://www.AAGL.org/jmig-21-4-JMIG-D-13-00678
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http://www.AAGL.org/jmig-21-4-JMIG-D-13-00678
S1553-4650(14)00206-4
DOI:
10.1016/j.jmig.2014.03.011
Reference:
JMIG 2277
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 14 December 2013 Revised Date:
13 March 2014
Accepted Date: 13 March 2014
Please cite this article as: Lee CL, Wu KY, Su H, Wu PJ, Han CM, Yen CF, Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery (NOTES): a series of 137 patients, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/j.jmig.2014.03.011. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Hysterectomy
by
Transvaginal
Natural
Orifice
Transluminal
2
Endoscopic Surgery (NOTES): a series of 137 patients
3
Chyi-Long Lee, MD, PhD; Kai-Yun Wu, MD; Hsuan Su, MD; Pei-Ju Wu, MD,
4
Chien-Min Han, MD, Chih-Feng Yen, MD.
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*The first 2 authors (Drs Lee and Wu) contributed equally to the study.
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From the Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital at
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Linkou and University (Drs Lee, K-Y Wu, Su, Han, and Yen); the Graduate Institute of
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Clinical Medical Sciences, Chang Gung University College of Medicine, Tao-Yuan (Dr Yen);
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and the Department of Obstetrics and Gynecology, Chung Shan Medical University
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Hospital, Taichung (Dr. P-J Wu), Taiwan, Republic of China.
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Corresponding author: Chih-Feng Yen, MD, Department of Obstetrics and
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Gynecology, Chang Gung Memorial Hospital at Linkou, 5, Fu-Hsin St, Kwei-Shan,
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Tao-Yuan, Taiwan 33305. Tel: +886-3-1200, E-mail: [email protected]
14
Author contributions: C.-L.L., K.-Y.W., H.S. and C.-F.Y. conceived and designed the
15
study; K.-Y.W., H.S., P.-J. W. and C.-M. H. acquired the data; C.-F. Y. analyzed and
16
interpreted the data; K.-Y.W. and C.-F. Y. drafted the manuscript; C.-L.L. and C.-F.Y.
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reviewed the data and revised the manuscript critically for scientific and intellectual
18
content. All authors approved the final version for submission.
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Funding: This study was partially supported by Chang Gung Memorial Hospital
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research grants CMRPG370151 and CMRPG381361. Dr C.-F. Yen is the principal
21
investigator.
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Financial Disclosure: All authors have no conflict of interest to be declared.
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Presentation: This study was presented in part at the 42nd Global Congress of
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Minimally Invasive Gynecology (Annual Meeting of the AAGL), Washington DC,
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November 10-14, 2013.
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Running title: Hysterectomy by Purely Transvaginal NOTES
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Précis
29 Transvaginal natural-orifice transluminal laparoscopic surgery (NOTES) is a safe
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and feasible technique to undergo hysterectomy.
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ABSTRACT
34
Study Objective: To evaluate the feasibility and safety of hysterectomy in benign
35
disease with transvaginal natural orifice transluminal endoscopic surgery (NOTES).
36
Design: Prospective observational study.
37
Setting: Tertiary referral medical center.
38
Patients: From May 2010 to August 2011, consecutive patients who were scheduled
39
for laparoscopic hysterectomy and without virginity or the suspicion of pelvic
40
inflammation, or cul-de-sac obliteration were included.
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Intervention: Total hysterectomy with transvaginal NOTES.
42
Measurements and Main Results: All included patients were 137, with mean age
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46.0±0.4 years and BMI 24.7±0.4 kg/m2 ([±SEM]), respectively, and transvaginal
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NOTES was successfully completed in 130 (94.9%) patients. 15 patients underwent
45
concurrent adhesiolysis and 17 with adnexal procedures. Mean uterine weight was
46
450.0±24.1 gm, where 45 (34.6%) patients had weights >500gm, and 7 (5.4%) patients
47
>1000gm. Mean operative time was 88.2±4.1 minutes, with mean blood loss
48
257.7±23.9 mL. Two patients encountered intraoperative hemorrhage or unintended
49
cystotomy, another 5 with failure of transvaginal colpotomy due to a very narrow
50
vagina, cul-de-sac obliateration by bowel adhesions, or mass obstruction, and all
51
these 7 (5.1%) patients were successfully dealt with transabdominal laparoscopy.
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Five (3.6%) patients experienced postoperative urinary retention or febrile morbidity,
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and recovered uneventfully with conservative treatments.
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Conclusion: Transvaginal NOTES is feasible to perform hysterectomy and can
55
undergo procedures hardly completed in conventional vaginal surgery, given that
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posterior colpotomy is achievable. This procedure was not impeded by the
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voluminous size of uterus, and was advantaged by the absolution of any abdominal
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incision.
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Keywords: Hysterectomy, laparoscopy, vaginal surgery, natural orifice transluminal
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endoscopic surgery (NOTES).
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Introduction Natural orifice transluminal endoscopic surgery (NOTES) is a novel concept
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of using the natural orifices of human bodies to be the surgical channels and avoid
66
visible abdominal scars [1]. Different techniques had been developed such as
67
transcolonic access and per-oral transgastric or transesophageal accesses, however,
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transvaginal access is the most frequently used approach for NOTES [2].
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The techniques of transvaginal endoscopy have been reported in gynecology
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[3-6], and termed ‘culdoscopy’ or ‘ventroscopy’ [7] in the past. With the criticisms of
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restricted visualization and limited operative capabilities, its application diminished
72
after the popularity of abdominal laparoscopy in the 1970s. Transvaginal
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hydrolaparoscopy (THL) developed later [8-10], this technique was mainly restricted
74
to the diagnostic evaluation of infertility.
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Though conventional vaginal surgeries has been a gynecologic expertise in
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daily practice, some procedures can only be achieved with palpation in some
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conditions, such as doing vaginal hysterectomy while the uterus is large or without
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descensus, or performing concomitant adnexal surgeries. We recently developed a
79
technique of transvaginal NOTES using the wound-retractor-and-glove system [1]
80
and demonstrated that transvaginal NOTES can perform not only adnexal
81
procedures [11, 12], but hysterectomies [13] as well. In our preliminary experience,
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transvaginal NOTES combines the features of vaginal surgery and the new
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techniques of single-port laparoscopic surgery, which widened the capability and
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achievability of conventional vaginal surgery in a variety of circumstances, and
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yielded a favorable result of scarless abdomen [13]. However, we also noted that
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transvaginal procedures are inherently quite different from that of transabdominal
87
approaches. The purpose of this study was to evaluate the feasibility and to explore
88
the possible limitations of hysterectomy performed with transvaginal NOTES in the
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daily practice for benign gynecologic disease.
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Materials and Methods This study was reviewed and approved by the Human Investigation Review
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Board of Chang Gung Memorial Hospital. All patients who underwent surgical
94
management gave their written informed consents. Experienced gynecologic
95
endoscopists performed all surgeries.
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96 Patients
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Patients scheduled for laparoscopic hysterectomy from May 2010 to August
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2011 in Chang Gung Memorial Hospital were prospectively included to perform
100
transvaginal NOTES. Conditions such as obesity (body mass index >30 kg/m2),
101
those who never had vaginal deliveries, those who needed concomitant adnexal
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surgeries, and those with a history of previous cesarean deliveries or abdominal
103
surgeries were not considered contraindications. However, patients of virginity,
104
suspected with severe pelvic adhesions from prior abdominal surgeries,
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tubo-ovarian abscesses, or endometriosis were excluded.
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Surgical techniques
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Previously published surgical techniques [1, 13] are described in brief as the
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following: Under general anesthesia with endotracheal intubation, patients were
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placed in Trendelenburg position with legs bandaged and supported in the stirrups.
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One 12-French Foley catheter was indwelled. The operation started as in
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conventional vaginal surgery with a circumcision of vaginal wall around the cervix
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and creating a 3-cm posterior colpotomy through the posterior fornix of the vagina.
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Then the uterosacral ligaments were dissected, and the uterine vessels sealed and cut
115
up to the level of isthmus with either suture-ligation or LigaSure system (Valleylab,
116
Boulder, CO) designed for laparotomy. With the exception of several initial patients,
117
anterior colpotomy was achieved first with the complete dissection of peritoneum
118
reflection at bladder base.
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The vaginal port was then established by inserting the inner rim of a small
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Alexis wound retractor (Applied Medical Resources Corp., Rancho Santa Margarita,
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CA) around the cervix and fixing from behind the colpotomy wound (Fig 1A), and
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the outer rim of the wound retractor outside the vagina was draped with the
123
disposable surgical glove in which 3 of the fingers were fixed with 10-mm or 5-mm
124
cannulas (Fig 1B). We used a 5-mm, 30-degree endoscope (KARL STORZ GmbH &
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Co. KG, Tuttlingen Germany) or a 10-mm conventional endoscope as visual media, a
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laparoscopic single tooth tenaculum to manipulate the uterus, and a 5-mm LigaSure
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system (Valleylab, Boulder, CO) designed for laparoscopy as energy source. All
128
other necessary instruments are the ordinary straight ones as are used in the
129
conventional laparoscopy.
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Transvaginal NOTES then began after adequate pneumoperitoneum. For the
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several initial patients, the vaginal ports were established prior to the opening of the
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peritoneum reflection at bladder base during the anterior colpotomy, so that the
133
peritoneum could be dissected first under endoscopic guidance. The remaining
134
structures going upward from the isthmic level, including broad ligaments, round
135
ligaments, ovarian ligaments and Fallopian tubes, were then sealed and cut with
136
LigaSure to complete the hysterectomy (Fig 2 A-D). If any adnexal lesions were
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found, enucleation, salpingectomy or salpingo-oophorectomy was performed
138
whenever appropriate [11]. After taking out the glove with cannulas, the uterus was
139
removed with morcellation through the vagina under the protection of a wound
140
retractor.
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Then, the NOTES resumed by readapting the surgical glove again to ensure
142
hemostasis and to overlook the whole pelvis and abdominal cavity. Finally, the
143
surgery ended after closure of the vaginal cuff and a routine checkup of cystoscopy.
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144 Treatment protocol
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We gave prophylactic antibiotics preoperatively with a single-dose of
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parenteral cefazolin, and postoperatively with cefazolin and gentamicin for 24 hours.
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The Foley catheter was indwelled overnight. According to the regulations of our
149
national insurance, patients could not be discharged until an afebrile status for at
150
least 24 hours, good wound healing, full recovery of urinary and gastrointestinal
151
functions and without evidence of surgical complications. Vaginal intercourse was
152
prohibited within 2 months after operation. Patients returned to our outpatient
153
clinic one week and one month after the surgery for check-up. Three months later,
154
patients were evaluated for general wellbeing and sexual function, including
155
dyspareunia or post-coital bleeding.
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Data analysis
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Continuous variables such as age, body mass index (BMI) and uterine weight
159
are presented as mean±SEM, whereas discrete variables such as parity are presented
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as median value and range. Descriptive statistics were performed using SPSS for
161
Windows, release 17.0.0/2008 (IBM-SPSS, Inc., Chicago, IL).
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Results From May 2010 to August 2011, we enrolled a total of 137 patients who had
164
preoperative benign diseases that required hysterectomy. Their demographics are
165
presented in Table 1. The study population was aged 46.0±0.4 years, the median
166
parity 2, and the mean BMI 24.7±0.4 kg/m2. Eight (5.8%) of the patients were
167
nulliparous, in addition to 26 (19.0%) patients without a history of vaginal deliveries.
168
50 (36.5%) patients had previous abdominal surgeries, including 38 (27.7%) cesarean
169
deliveries, 7 (5.1%) laparotomies, and 5 (3.6%) laparoscopies.
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Hysterectomies with pure transvaginal NOTES was successfully completed in
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130 (94.9%) of the 137 patients, while 7 (5.1%) patients were converted to
172
conventional laparoscopy. Among the 130 patients, concomitant pelvic surgeries
173
including 3 enucleations, 6 salpingectomies, 8 salpingo-oophorectomies, and 15
174
extensive adhesiolysis, were also carried out successfully purely with transvaginal
175
NOTES. As presented in Table 2, the mean uterine weight in this series was
176
450.0±24.1 gm, in which 39 (30%) patients had weights between 300gm and 500 gm,
177
and 45 (34.6%) patients had weights >500gm. 7 (5.4%) patients had uterine weights
178
>1000gm, up to an extreme value of 1630gm. The mean operation time was 88.2±4.1
179
minutes. Mean blood loss was 257.7±23.9 mL, mean decrease of hemoglobin between
180
pre-operation and the first post-operation day was 1.2±0.1 g/dL, and 10 (7.7%)
181
patients received blood transfusions intraoperatively. Mean post-operative hospital
182
stay was 2.8±0.07 days. The final pathologic reports were leiomyomas and/or
183
adenomyosis, with the exception of one patient with endometrial stromal sarcoma
184
(Table 2).
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In the current series, there were 2/137 (1.5%) patients with intraoperative
186
complications and 5/137 (3.6%) patients with a failed attempt of vaginal approach,
187
and all 7 patients were converted to conventional laparoscopy to complete the
188
surgeries, as presented in Table 3. The conversion rate was 5.1% (7/137) on the
189
intention-to-treat basis. As for the intraoperative complications, one patient had an
190
unintended cystotomy at trigone during anterior colpotomy, which was revealed
191
immediately by palpating the Foley balloon through a 1-cm hole of perforation. The
192
operation was then shifted to conventional laparoscopy where the bladder
193
perforation was repaired with primary sutures and an indwelling Foley catheter for
194
7 days. No sequela was noted at the one-month follow up. With another patient, we
195
encountered a profound vaginal bleeding from the regurgitation of a very large
196
uterus, which obscured the operation field that made the transvaginal approach very
197
difficult. Therefore the approach was converted to conventional laparoscopy.
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There were 5 patients with a failed attempt from transvaginal NOTES and we
199
managed with conversion to transabdominal laparoscopy. One nullipara had a very
200
narrow vagina that inhibited the downward traction of the large uterus. Two
201
patients had a large uterine myoma at the lower anterior low corpus that obstructed
202
the way of anterior colpotomy, and another patient had a large intraligamentous
203
uterine myoma at the lower corpus, which also obstructed the way of transvaginal
204
colpotomy. The last case had severe endometriosis in the cul-de-sac, which
205
developed dense adhesions among the uterosacral ligaments and the rectum that
206
obstructed the way of posterior colpotomy.
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We encountered 5/137 (3.6%) patients with postoperative morbidities, as
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listed in Table 4. One patient had a difficulty voiding postoperatively. A Foley
209
catheter was indwelled for five days and the voiding function recovered to normal.
210
Four patients were complicated with postoperative febrile morbidity. Of the four,
211
three presented with severe lower abdominal pain, leukocytosis and elevated
212
C-reactive protein one week after discharge and required re-hospitalization for
213
antibiotics treatment. All these patients had negative findings in ultrasonorgaphy
214
and computed tomography, and recovered uneventfully after empiric antibiotics
215
with ceftriaxone and metronidazole for three to seven days. The other febrile patient
216
developed a urinary tract infection one week after discharge. She was re-admitted
217
for hydration, empiric antibiotics for 3 days, and recovered.
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After a follow-up for up to three months after operation, all patients had good healing of vaginal cuff with normal voiding and sexual functions. All the patients
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completed with pure transvaginal NOTES were highly satisfied with the absolution
221
of any incisions on their abdominal wall.
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Discussion The current series proved our concept that hysterectomy performed with
224
transvaginal NOTES [13] is feasible for daily practice, with a success rate of almost
225
95%. Instead of using an additional abdominal port as the so-called hybrid-NOTES
226
[14-16], our method was advantaged by undergoing completely a single-port
227
laparoscopy-like technique through purely vaginal approach, and eliminate any
228
wound in abdominal wall [17].
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We learned in the current series that transvaginal NOTES can be applied to
230
accomplish some difficult procedures in conventional vaginal surgeries, with few
231
exceptions. Conventional vaginal hysterectomy could be prohibited by the enlarged
232
size of uterus, or the condition of undescensus, or by a restricted vaginal space such
233
as in women who never experienced vaginal deliveries. In the current series, the
234
mean weight of the uterine specimen was nearly 460 gm, in which 45 (34.6%)
235
patients had uterine weight > 500gm and 7 of them >1000gm, so that the size and
236
weight of the uterus did not seem to be a hamper. There were also 8 (5.8%) patients
237
of nulliparity and 26 (19.0%) patients never experienced vaginal delivery. However,
238
hysterectomies in the current series could generally be completed uneventfully with
239
transvaginal NOTES in almost all these situations, therefore the restricted vaginal
240
space and uterus without descensus were not contraindications.
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Besides, adhesiolysis and adnexal procedures in conventional vaginal
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surgeries were also very difficult because of the limited accessibility in the restricted
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space. In the current series, 33 of 130 (25.4%) patients were noted with adnexal
244
pathologies or pelvic adhesion. As a result, transvaginal NOTES can feasibly
15 Lee, Wu & Su et al.
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undergo the concurrent salpingectomy, salpingo-oophorectomy, the adhesiolysis,
246
and enucleation of ovarian tumor with suture repair without additional difficulties
247
to hysterectomy per se, as was reported in our previous publication [11]. In addition,
248
delicate hemostasis was achieved by direct vision with laparoscopy before the
249
closure of vaginal wound. Therefore, transvaginal NOTES extended the scope and
250
capability of the conventional vaginal surgery.
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In our experience, one advantage of the transvaginal NOTES for hysterectomy
252
was with a shorter operating time than the abdominal laparoscopic hysterectomy.
253
Obviously we avoided the time of opening and closing the abdominal wound.
254
Besides, because the uterus was directly in traction and handled by the operator and
255
not the assistant, the communication with the assistant for adjusting the uterine
256
position could be spared, which made the progress of the operation more fluent and
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hence could contribute to the shortening of the operating time.
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Another advantage of the transvaginal NOTES for hysterectomy is its earlier
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blockage of the uterine vessels. Since the uterine arteries were supplied at the level
260
of the isthmus, it would be more accessible from the transvaginal approach, which is
261
beneficial especially in situations with a large uterus. Since in most situations, the
262
uterine myoma or adenomyosis was located at uterine corpus and the cervix
263
remained small, the trial to approach uterine arteries from the abdominal route was
264
usually interfered by the voluminous corpus, which sometimes caused more
265
bleeding. However, sealing the uterine vessels transvaginally in these situations was
266
much easier, and with that being achieved at the beginning of the operation made
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the procedure afterward almost bloodless and efficient. In the current series, we
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found that intraoperative blood loss was less than that of conventional laparoscopic
269
hysterectomy. Further randomized comparative study is needed in the future to
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prove our observation. There were 10 patients in the current series needing transfusion, all with
272
uterine weight >500 gm, and 4 of them with uterine weight >1000 gm. Though the
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size of the uterus could be one of the risk factor of transfusion, however, other
274
factors such as the existence of pelvic adhesion, the constrictiveness of pubic arch,
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the location and shape of myoma, as well as the abundant and engorged vessels on
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the uterus, etc., could also contribute to increased blood loss. It is hard to conclude a
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general rule of decreasing intraoperative bleeding in these different situations, but
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the increase of surgeons' experience in blocking the vessels seemed improving the
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results. In further analysis of the current series, 4 patients of the transfusion were
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within the first 10 cases, another 2 were within the subsequent 20 cases, and the
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other 4 scattered in the later 100 cases. This phenomenon may be a support of the
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existence of "learning curve".
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However, patients of conversion and transfusion in the current study were
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different. Only 2 of the 7 patients converted to conventional laparoscopy had
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transfusion, as presented in Table 3, in which only one for the reason of hemorrhage.
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That is a case we failured to seal the multiple engorged vessels in a patient with
287
voluminous uterus. Failure to effectively seal these vessels would cause a profound
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bleeding from the engorged vessels as well as the regurgitation from the large uterus.
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This in turn resulted in a large accumulation of blood in the transvaginal port and
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blurred the vision of transvaginal laparoscopy, which induced a vicious cycle of
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longer operating time and more blood loss. In this situation, the surgery would
292
inevitably be converted to the transabdominal approach. We found that the failure of transvaginal NOTES almost arose from the
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impedance of the transvaginal colpotomy in some way, if not from the
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intraoperative complications. In the current series, one patient had a very narrow
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vagina, which made the transvaginal operation nearly impossible. Another patient
297
had bowel adhesions in the cul-de-sac, which was impedance to posterior colpotomy,
298
and necessitated the conversion to transabdominal laparoscopy. Two other patients,
299
each with a large uterine myoma at the lower anterior corpus, had a downward
300
traction of the uterus that simultaneously obstructed the way of anterior cul-de-sac
301
impeded the way of anterior colpotomy. In these situations, transabdominal
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laparoscopy was much safer and easier than the transvaginal NOTES.
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Regarding the follow-up of postoperative patients, we found pelvic infection
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in 4/130 (3.1%) patients occurring on the average of 10th day after operation, and all
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these patients were treated recovered uneventfully with parenteral antibiotics. The
306
vagina has been criticized for its lack of asepticism [18, 19], and as these incidences
307
usually happened within the first 20 cases of different surgeons, therefore we
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hypothesized that the postoperative infections could have possibly arisen from the
309
unskilled techniques of colpotomy or incomplete hemostasis. This issue warrants
310
further investigation while we gain more experience.
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Dyspareunia and sexual abstinence are the other two concerns. However,
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these concerns were universal for all patients undergoing vaginal surgery with
313
vaginal cuff sutures, and not specific for NOTES. In the present series, sexual
18 Lee, Wu & Su et al.
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abstinence is routinely recommended for 6 to 8 weeks in our practice for
315
transvaginal NOTES, so no patients in our series had problems with dyspareunia or
316
post-coital bleeding at three-month follow up. In conclusion, hysterectomy is feasible to be performed with transvaginal
318
NOTES. Though there were a few complications in this series, but all were resolved
319
with abdominal conventional laparoscopy uneventfully. The advantages of
320
transvaginal NOTES we learned in the current series are that we always can see
321
clearly under the visual guidance of laparoscope and operate precisely by the handle
322
of endoscopic instruments, in comparisons with that some procedures in the
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conventional vaginal surgeries can only be achieved with palpation in some
324
conditions. It appears that the only impeding factor of transvaginal NOTES is the
325
obstruction of cul-de-sac to avoid the performance of transvaginal posterior
326
colpotomy, however, once this step was successfully done, the size of the specimen
327
would no more be the impeding factors of the operation process. We also found that
328
performing hysterectomy with transvaginal NOTES was generally beneficial with a
329
short operating time and high patient satisfaction as in the conventional vaginal
330
surgery due to the absence of any abdominal wound.
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Therefore we suggest that transvaginal NOTES is an ideal approach for
332
hysterectomy in almost all conditions given that transvaginal colpotomy can be
333
achieved. Further comparative studies or even randomized controlled trials should
334
be carried out to confirm its advantages and significance in clinical practice.
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19 Lee, Wu & Su et al.
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Acknowledgements: We thank Lulu Huang, MD for her assistance in editing the manuscript.
337
Disclosure Statement: Drs CY Lee, KY Wu, H Su, PJ Wu, CM Han and CF Yen report no
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conflict of interest. This study was supported partially by Chang Gung Memorial Hospital
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research grants CMRPG370151 and CMRPG381361. Dr C.-F. Yen is the principal investigator.
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References
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Lee CL, Wu KY, Su H, Wu PJ, Han CM, Yen CF. Natural Orifice Transluminal Endoscopic Surgery (NOTES) in Gynecology. Gynecol Minim Invasive Ther. 2012
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Ott Dv. Die Beleuchtung der Bauchhohle (Ventroskopie) als Methode bei Vaginaler Coeliotomie. Abl Gynakol. 1902;231:817-23.
8.
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Clyman MJ. A new panculdoscope--diagnostic, photographic, and operative aspects. Obstet Gynecol. 1963 Mar;21:343-8.
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Cheng MC, Khew KS, Chen C, Ratnam SS, Seng KM, Tan WK. Culdoscopic ligation as an outpatient procedure. Am J Obstet Gynecol. 1975 May 1;122(1):109-12.
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Peretz A, Sharf M. Culdoscopy in gynecologic diagnosis. A review of 404 cases of endoscopic examination. Am J Obstet Gynecol. 1961 Sep;82:582-7.
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Decker A. Culdoscopy; its diagnostic value in pelvic disease. J Am Med Assoc. 1949
De Wilde RL. Transvaginal hydrolaparoscopy. J Am Assoc Gynecol Laparosc. [Letter].
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Santos BF, Hungness ES. Natural orifice translumenal endoscopic surgery: progress
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Darai E, Dessolle L, Lecuru F, Soriano D. Transvaginal hydrolaparoscopy compared
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with laparoscopy for the evaluation of infertile women: a prospective comparative
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blind study. Hum Reprod. 2000 Nov;15(11):2379-82.
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Moore ML, Cohen M, Liu GY. Experience with 109 cases of transvaginal hydrolaparoscopy. J Am Assoc Gynecol Laparosc. 2003 May;10(2):282-5.
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Lee CL, Wu KY, Su H, Ueng SH, Yen CF. Transvaginal Natural-Orifice Transluminal Endoscopic Surgery (NOTES) in Adnexal Procedures. J Minim Invasive Gynecol. 2012
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Jul;19(4):509-13. 12.
Lee CL, Wu KY, Su H, Yen CF, Ueng SH. Regarding "transvaginal single-port natural orifice transluminal endoscopic surgery". J Minim Invasive Gynecol. [Letter]. 2013
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Su H, Yen CF, Wu KY, Han CM, Lee CL. Hysterectomy via transvaginal natural orifice
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transluminal endoscopic surgery (NOTES): Feasibility of an innovative approach.
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Taiwan J Obstet Gynecol. 2012 Jun;51(2):217-21.
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Moen MD, Noone MB, Elser DM. Natural orifice hysterectomy. Int Urogynecol J
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Pelvic Floor Dysfunct. [Review]. 2008 Sep;19(9):1189-92. 15.
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Lee D, Dillon B, Lemack G, Gomelsky A, Zimmern P. Transvaginal mesh kits-how
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"serious" are the complications and are they reversible? Urology. 2013
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Zorron R, Maggioni LC, Pombo L, Oliveira AL, Carvalho GL, Filgueiras M. NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc. 2008
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Hackethal A, Sucke J, Oehmke F, Munstedt K, Padberg W, Tinneberg HR. Establishing transvaginal NOTES for gynecological and surgical indications: benefits, limits, and
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patient experience. Endoscopy. 2010 Oct;42(10):875-8. 18.
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Rattner D, Kalloo A. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. October 2005. Surg Endosc. 2006 Feb;20(2):329-33.
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Hazey JW, Narula VK, Renton DB, Reavis KM, Paul CM, Hinshaw KE, et al.
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trial. Surg Endosc. 2008 Jan;22(1):16-20.
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Figure Legends
393 Figure 1. Photograph shows how the portal of transvaginal NOTES was established.
395
(A) The small Alexis wound retractor (Applied Medical Resources Corp., Rancho
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Santa Margarita, CA) was inserted through and fixed against the colpotomy wound;
397
and (B) a disposable glove attached with three cannulas was draped onto the
398
retractor. The insufflating tube was connected to one of the cannulas to establish
399
pneumoperitoneum.
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Figure 2. Intraoperative photographs from a representative patient shows some
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portion of the endoscopic procedures. (A) A laparoscopic tenaculum forceps grasped
403
at the right lower corpus to expose the right ovary; (B) The left ovarian ligament was
404
exposed when the round ligament was partially done by the LigaSure. (C) Selective
405
right salpingectomy can be done with the preservation of ovary. (D) The left
406
tri-pedicle (the tube, ovarian ligament and round ligament) has been separated from
407
the uterus, and hence the uterus could be removed from the colpotomy wound. (Ut:
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uterus, Ov: ovary, Tu: tube, R: rectum)
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46.0 ± 0.4
Parity (median [interqartile range])
2 [1 – 3]
P=0 (Nulliparous), N (%)
8 (5.8)
P>1
129 (94.2)
With vaginal delivery, N (%)
103 (75.2)
Without vaginal delivery, N (%)
26 (19.0)
BMI (Kg/m2, mean±SEM)
24.7 ± 0.4
Previous abdominal surgery, N (%)
Laparotomy, N (%)
3
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50 (36.5)
38 (27.7)
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Age (years, mean±SEM)
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Table 1. Patients’ characteristics (N=137)
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Table 2. Surgical Outcomes of the 130 patients who completed NOTES (N=130) 88.2±4.1
Estimated blood loss (ml, mean±SEM)
257.7± 23.9
Decrease of hemoglobin (g/dL, mean±SEM)
1.2 ± 0.1
Blood transfusion, N (%)
10 (7.7)
Uterine weight (gm, mean±SEM)
450.0 ± 24.1
Hospital stay (days, mean±SEM))
Enucleation, N (%) Salpingectomy, N (%)
2.8 ± 0.1
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33 (25.4) 3 (2.3) 6 (4.6) 8 (6.2)
Extensive adhesiolysis, N (%)
15 (11.5)
Posterior colporrhaphy
1 (0.7)
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Pathologic report
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Leiomyoma, N (%)
60 (46.2)
Adenomyosis, N (%)
18 (13.8)
Leiomyoma and adenomyosis, N (%)
51 (39.2)
Endometrial stromal sarcoma, N (%)
1 (0.7)
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C/S BMI (times) (kg/m2)
Op indication
Op time (min)
Cases of intraoperative complications and conversion
1
50
2
0
24.0
Myoma
267
2
49
2
0
21.3
Myoma
116
Admy
Blood loss (mL) 1500 150
Cases of failed attempt from transvaginal NOTES and conversion
3
40
2
2
38.4
4
43
2
0
32.4
5 6
42 45
0 2
0 1
20.0 20.0
7
40
2
2
20.8
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+ 0.3
Uterine weight (gm)
Length Reasons of failure of stay (day)
Y
1400
3
+ 0.1
N
377
7
+ 0.8
Y
711
4
204
100
- 2.5
N
487
2
168 106
300 200
- 0.8 - 1.9
N N
982 172
3 4
161
500
- 2.9
N
220
3
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Myoma Admy Myoma Admy Myoma Myoma Admy Myoma Admy
Hb BT change
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Parity
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Table 3. Patients with intra-operative conversions or complications
Massive vaginal bleeding Bladder perforation
Anterior low corpus myoma Broad ligament myoma Narrow vagina Rectum adherent to uterosacral ligament Anterior low corpus myoma
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Number (% in N=137) 1 (0.7%)
Febrile morbidity, N (%)
4 (2.9%)
Lower abdominal pain, N (%)
3 (2.2%)
Urinary tract infection, N (%)
1 (0.7%)
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Urinary retention, N (%)
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