Accepted Manuscript Total Vaginal NOTES Hysterectomy (TVNH):A new approach to hysterectomy via Natural Orifice Transluminal Endoscopic Surgery Jan Baekelandt PII:
S1553-4650(15)00415-X
DOI:
10.1016/j.jmig.2015.05.015
Reference:
JMIG 2579
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 5 March 2015 Revised Date:
18 May 2015
Accepted Date: 20 May 2015
Please cite this article as: Baekelandt J, Total Vaginal NOTES Hysterectomy (TVNH):A new approach to hysterectomy via Natural Orifice Transluminal Endoscopic Surgery, The Journal of Minimally Invasive Gynecology (2015), doi: 10.1016/j.jmig.2015.05.015. 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
Total Vaginal NOTES Hysterectomy (TVNH):
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A new approach to hysterectomy via Natural Orifice Transluminal Endoscopic Surgery
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Jan Baekelandt
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Department of Obstetrics and Gynaecology, Imelda Hospital Bonheiden, Belgium
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Corresponding author contact information Jan Baekelandt AZ Imelda Hospital Imeldalaan 9, 2820 Bonheiden, Belgium Email: [email protected] Phone: +3215/50 61 89 Fax: +3215/50 59 29
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Keywords
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Transvaginal - NOTES - hysterectomy - frugal innovation - standard reusable instruments - low cost single port
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device - TVNH - VANH - VAMIS - vNOTES
ACCEPTED MANUSCRIPT 51 Abstract
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The aim of this study was to demonstrate the feasibility of a total hysterectomy performed entirely by
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transvaginal natural orifice transluminal endoscopic surgery (vNOTES). Conventional, reusable laparoscopic
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instruments were used, inserted through an inexpensive, self-constructed single port device.
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Ten Total Vaginal NOTES Hysterectomies (TVNH) were performed by a single surgeon (BJ). The self-
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constructed single port device was made by assembling a surgical glove, a wound protector or modified
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laryngeal mask airway, one reusable 10 mm trocar, and four reusable 5 mm trocars. This gloveport was inserted
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into the vagina to create a pneumovagina. The conventional steps of a vaginal hysterectomy were followed, but
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performed endoscopically with standard reusable endoscopic instruments. Patient and perioperative data were
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analysed.
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No conversion to standard laparoscopy or laparotomy was necessary in any of the ten patients who underwent a
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TVNH. Mean operation time was 97 min (60-120 min); mean drop in haemoglobin level was 1.5 g/dl ( 0.5-2.4
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g/dl). There were no operative complications, and post-operative pain scores were very low.
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This first report on a small number of patients demonstrates that TVNH is possible. Incorporating the advantages
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of endoscopic surgery it broadens the indications for vaginal hysterectomy and helps overcome its limitations.
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Simultaneously the NOTES approach avoids abdominal wall wounds and trocar related complications. TVNH is
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feasible, even when performed with reusable, conventional laparoscopic instruments. This frugally innovative
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technique also enables surgeons to perform hysterectomies by vNOTES in low resource settings.
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Introduction
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Aiming to reduce surgical morbidity, the evolution from laparotomy to laparoscopy has now broadened to
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include even less invasive techniques, such as single incision laparoscopic surgery (SILS), and natural orifice
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transluminal endoscopy (NOTES). Minimally invasive surgery not only improves cosmetic outcome, but also
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reduces surgical injury. This in turn decreases the inflammatory and neuroendocrine response resulting in less
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post-operative pain and quicker recovery (1, 2).
ACCEPTED MANUSCRIPT NOTES reaches the abdominal cavity by scar-free means, i.e. numerous surgical procedures are performed via a
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natural body orifice. This technique has gained popularity amongst general surgeons, gynaecologists, urologists
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and gastroenterologists over the past few years and its feasibility and safety have been approved (3).
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NOTES can be performed via a variety of approaches including stomach, oesophagus, bladder, and rectum, but
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the majority of NOTES procedures have been performed transvaginally (4). The vagina can be easily
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decontaminated and provides direct access. Culdotomy has been used widely for several surgical procedures (not
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only by gynaecologists but also by general surgeons for extraction of large specimens) and it has been approved
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as safe and easy to close (5).
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In hybrid NOTES the surgical procedure is performed through a natural body orifice with transabdominal
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assistance. The term pure NOTES refers to procedures that involve only transluminal access.
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Given its potential benefits, including scarless intervention, fewer port-related complications, and less painful
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and faster post-operative recovery, transvaginal pure NOTES (vNOTES) for benign adnexal masses was
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introduced into our surgical practice in November 2013. After one year experience with vNOTES for adnexal
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surgery, the feasibility of performing a total hysterectomy entirely via vNOTES was assessed. Hysterectomy via
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NOTES, after performing an anterior and posterior colpotomy and transsecting the sacro-uterine ligaments via
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classical open vaginal surgery, has been described (6,7). We refer to this technique as vaginally assisted NOTES
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hysterectomy (VANH) as the first part of this procedure is performed by conventional vaginal surgery. Despite
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experience in vaginal surgery (BJ is gynaecological oncological surgeon, experienced in Schauta surgery (8,9)),
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it is suggested that, for most gynaecological surgeons, it can be challenging to perform an anterior and posterior
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colpotomy, and transsect the sacro-uterine ligaments (as required for VANH) in patients without any uterine
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prolapse or in patients with a narrow vagina (7). In addition, the complication rate for vaginal hysterectomy is
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higher in nulliparous women than in parous women (10). We therefore wanted to evaluate the feasibility of
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performing a total vaginal NOTES hysterectomy (TVNH), where the entire procedure is performed via vNOTES
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using endoscopic instruments. Our initial clinical experience with TVNH is described here. A full Poor Man’s
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NOTES approach was used (11). The feasibility and surgical outcome of TVNH when performed with only
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conventional, reusable laparoscopic instruments, and an inexpensive, self-constructed single port device that can
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be quickly and easily assembled, was evaluated. We aimed to demonstrate the possibility of performing a TVNH
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and that it is not necessary to use expensive, commercially available disposable SILS-ports, other disposable
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instruments, or sealing devices, to perform a total hysterectomy completely by vNOTES.
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Materials and methods
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Patients
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A single surgeon (BJ) performed 10 TVNH’s to evaluate the feasibility of the technique. To assess if a
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pneumovagina could be maintained in parous and nulliparous women,
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vaginally and 5 patients who had delivered vaginally were selected. All patients were selected for hysterectomy
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due to benign gynaecological disease. Patients were selected based on the following criteria: no contraindication
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for general anaesthesia, pneumoperitoneum or Trendelenburg position; no fixed uterus, strong pelvic adhesions
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or nodularity in the Pouch of Douglas on clinical examination; no history of pelvic inflammatory disease; no
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suspicion for malignancy. Obesity (BMI > 30) was not considered to be an exclusion criteria.
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The following patient and perioperative data were collected and retrospectively analysed: patient age, body mass
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index (BMI), parity, history of vaginal delivery, previous pelvic surgery, type of surgery, total operating time,
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serum hemoglobin (Hb) drop (change between the preoperative Hb and postoperative Hb one day after surgery),
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peri-operative complications, and postoperative pain score.
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The duration of surgery was defined as the time from the placement of the Foley catheter to the end of vaginal
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closure. Bowel, bladder, ureteral or vascular injuries, as well as blood loss > 300 ml were considered as
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intraoperative complications. Short-term postoperative complications were identified to be urinary tract
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infection, postoperative ileus, vaginal vault bleeding or infection, or hematuria.
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Postoperative pain was assessed using the visual analogue pain scale (VAS) (scoring from 0 = no pain, to 10 =
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worst imaginable pain). The VAS score was evaluated at 6 and 24 hours postoperatively. All patients received
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the same intraoperative analgesia: intravenous paracetamol 1000 mg and ketorolac trometamol 20 mg.
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Postoperative pain was managed by paracetamol 1000 mg and ketorolac trometamol was administered on
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patient’s demand.
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Prophylactic intravenous antibiotic therapy, cefazoline 2 g and metronidazol 500 mg, was administrated during
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surgery.
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No vaginal intercourse was allowed for 6 weeks after the procedure. Each patient was re-assessed at the post-
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operative consultation 6 weeks after surgery.
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5 patients who had not delivered
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Surgical technique
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The patient was placed in lithotomy position under general anaesthesia.
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performed to exclude pelvic adhesions or obliteration of the Pouch of Douglas.
A rectovaginal examination was
ACCEPTED MANUSCRIPT Construction of the low cost NOTES port:
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For the five patients who had not delivered vaginally, an Alexis Wound Protector/Retractor (Applied Medical,
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Rancho Santa Margarita, CA, USA) attached to a size 8 surgical glove was used. One finger of the surgical
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glove was incised to place a 10 mm reusable trocar for CO2 insufflation and laparoscope insertion. Four 5 mm
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reusable trocars were placed through the remaining fingers for insertion of the reusable laparoscopic instruments
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(Figure 1). In nulliparous women the ring of the wound protector holds the gloveport in the vagina during the
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procedure. CO2 insufflation at 15mmHg does not dislodge the port.
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For the five patients who had delivered vaginally, the same glove construction was used, but it was attached to
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an opened size 5 laryngeal mask airway (LMA) instead of a wound protector. The central part of the LMA was
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excised, leaving only the outer rim and inflatable cushion. The wrist side of the glove (with trocars in the fingers)
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was passed through the opening of the LMA and folded around the cushion part of the LMA (Figure 2). After
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inserting the LMA into the vagina, the cushion part was inflated and an orthostatic wound protector was placed
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in the LMA to hold it in place in the vagina. Tightening the orthostatic wound protector fixes the LMA in the
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caudal part of the vagina and prevents the CO2 insufflation from pushing the vaginal port out of the vagina.
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154 Endoscopic equipment:
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We used a standard rigid zero-degree 10 mm laparoscope. Only reusable conventional laparoscopic instruments
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were used: a bipolar forceps, a pair of cold scissors, a grasping forceps (Manhes), a monopolar hook, and a
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suction-irrigation cannula. No disposable instruments or sealing devices were used.
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Procedure description (Video 1)
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The operation field was disinfected and draped. A Foley catheter was placed and the self-constructed NOTES
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port was placed into the vagina. CO2 was insufflated at 15 mmHg to maintain an adequate pneumovagina.
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With traction placed on the uterine cervix using the Manhes forceps the cervix was circumcised using the
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monopolar hook. At the anterior fornix the vaginal mucosa and the bladder were pushed up along the uterine-
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cervical fascia using a small swab in the atraumatic grasper, while maintaining traction on the cervix using the
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Manhes forceps. Once the peritoneum between the bladder and the uterus could be identified, it was opened
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using cold scissors. The same technique was used in the posterior fornix until the peritoneum of the Pouch of
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Douglas could be visualised and opened.
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ACCEPTED MANUSCRIPT Once the anterior and posterior peritoneum were opened, both sacro-uterine ligaments were coagulated using the
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bipolar forceps and subsequently transsected using the cold scissors. After identification of both ureters, this
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procedure was repeated, caudally to cranially, for the remainder of the parametrium, the uterine arteries and the
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ovarian ligament, and Fallopian tube. In patients where a bilateral adnexectomy was performed, the
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infundibulopelvic ligament was transsected instead of the ovarian ligament and Fallopian tube. One patient had
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an 8 cm ovarian cyst. In this case the infundibulopelvic ligament was transsected after having first transsected
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the ovarian ligament and Fallopian tube to place the free uterus in the upper abdomen, thus allowing space to
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perform the adnexectomy.
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In patients with a small uterus, the entire procedure was performed with the NOTES port in the vaginal introitus.
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In patients with a larger uterus, the NOTES port was moved up from the introitus into the Pouch of Douglas after
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transsecting the sacro-uterine ligaments. This significantly improved visualisation.
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After haemostasis and rinsing of the peritoneal cavity, the pneumoperitoneum was deflated and the port device
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was removed. The uterus (and adnexae) were extracted and the colpotomy was closed using a Vicryl-1 (Ethicon,
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Piscataway, NJ, USA) suture.
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183 Results
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Ten TVNH’s were successfully performed by Poor Man’s tNOTES using conventional, reusable laparoscopic
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instruments. No conversion to standard multi incision laparoscopy or laparotomy was necessary. In four patients
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one or both adnexae were also removed; one of them had an 8 cm mucinous cystadenoma.
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Table 1 presents an overview of patient and perioperative data. Individual patient details are presented in Table
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2. Mean operation time was 97 minutes. Five patients had had previous pelvic surgery. There were no
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intraoperative complications. One patient had a postoperative cystitis for which oral antibiotic therapy was
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administered; and one patient had a small vault haematoma that was managed conservatively under antibiotic
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cover. The mean drop in hemoglobin level was 1.5 g/dl. Most patients scored a low postoperative pain score
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(range 1-2) 24 hours after surgery. All uteri were benign upon pathological examination (specimen weight 51-
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353g).
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As these were the first 10 patients to be operated by a new surgical technique, we requested all patients to remain
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hospitalised for 72 hours for comprehensive follow up. Each patient was examined six weeks after surgery.
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There was no vaginal wound infection nor dehiscence, and none of the patients complained of pain during
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pelvic examination. All patients were in good health and were back at work.
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ACCEPTED MANUSCRIPT 199 Discussion
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In this feasibility study, TVNH for benign uteri was successfully performed in ten patients, using only
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conventional, reusable laparoscopic instruments and a self-constructed NOTES port. The procedures were
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completed within a reasonable operation time and without major complications, no conversion to laparotomy or
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standard laparoscopy was necessary. We demonstrated that this technique can be used in parous and nulliparous
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women, provided that a different port is constructed to maintain a pneumovagina.
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To the best of our knowledge this is the first report of TVNH being successfully performed on patients. A
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PubMed search revealed that a cadaveric model for hysterectomy by Vaginal Access Minimally Invasive
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Surgery (VAMIS) has recently been presented (12). The major difference between TVNH and a VANH lies in
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the opening of the anterior and posterior peritoneum and the transsection of the sacro-uterine ligaments. This is
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performed entirely endoscopically in the TVNH, whereas it is performed by classical vaginal surgery in a VANH
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(Table 3). The TVNH technique can therefore also be used in nulliparous patients, patients without uterine
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prolapse, and patients with a narrow vagina where classical vaginal surgery can be more challenging (7,10).
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An inexpensive, self-constructed single port device, that can be quickly and easily made, was used. By
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combining this self-constructed port device with easily available, conventional, and reusable laparoscopic
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instruments, this study shows that the TVNH technique is feasible without increasing the cost of laparoscopic
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surgery. This frugally innovative technique can thus potentially be performed in a low resource setting. Poor
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Man’s vNOTES has previously been described as an approach for adhaesiolysis (11).
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A self-constructed port using a surgical glove has advantages when compared to commercial ports. It is less
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costly, it has flexible material that enables greater manipulation of instruments, and a greater number and size of
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instruments can be passed through the incision. Multiple instruments can therefore be left in place in the trocars
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limiting the number of instrument changes and port transfers. In our experience constructing a Poor Man’s
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NOTES port takes approximately 3 minutes for a gloveport with wound protector and approximately 5 minutes
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for a gloveport with LMA. It is constructed by the first assistant while the surgeon disinfects and drapes the
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patient and therefore does not add to the total operation room time.
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Conventional transvaginal surgery has the advantage of the absence of abdominal scarring and is the preferential
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approach to hysterectomy (13). By performing vNOTES, the technical drawbacks of transvaginal surgery,
ACCEPTED MANUSCRIPT including limited visualisation to attempt good hemostasis and difficulty in performing adnexectomy in case of
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adhesions between the adnexa and the uterus, can be overcome. Additionally, vNOTES eliminates the risk of
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trocar related complications and induces less post-operative pain (14). It has been demonstrated that very large
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uteri can be removed via VANH, and that ligating the uterine vessels transvaginally before dissecting the rest of
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the uterus, results in less blood loss compared to a transabdominal laparoscopic approach where there is more
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manipulation before occlusion of the feeding vessels (6,7). This still needs to be demonstrated in further studies
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for TVNH but as the second part of the procedure is identical to VANH, the same advantage can be expected.
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TVNH also enables the removal of uteri when the cervix is less accessible for classical vaginal surgery or
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VANH.
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To perform vNOTES various technical difficulties, comparable to those for transumbilical SILS, need to be
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overcome. The surgeon has to deal with problems due to instrument collision, limited triangulation, and reduced
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traction of tissue (15, 16). Due to the vagina providing a more flexible entry point compared to the infra-
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umbilical fascia opening, these difficulties were found to be less restricting when compared with SILS. Further
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advances in optics, instruments and robotic surgery will help overcome these technical challenges, enabling
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more surgeons to perform more hysterectomies via transvaginal access.
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One could argue the possibility of pelvic infection after vaginal surgery, however none of our patients presented
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with this complication after the TVNH procedure. Previous studies have also shown that post-operative pelvic
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infection is unlikely to happen particularly when prophylactic antibiotics are administered (7, 17). As the vaginal
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vault is closed in the same way as in a classical vaginal hysterectomy, no differences in incidence of dyspareunia
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are to be expected. As was the case for our study protocol, sexual abstinence should be recommended for six to
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eight weeks, as is the recommendation for conventional transvaginal surgery (7).
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The same contra-indications should be considered before performing TVNH as before performing vNOTES. In
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patients with a massive hemoperitoneum the endoscopic view will get disturbed (18). If Pouch of Douglas
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adhesions can be expected, a thorough pelvic examination should be performed prior to surgery, and in case of
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unexpected Pouch of Douglas obliteration, conversion to transabdominal laparoscopy should be considered.
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Virginity is another contra-indication for vNOTES. Nulliparity or absence of history of vaginal delivery are not
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contra-indications to perform vNOTES.
ACCEPTED MANUSCRIPT 259 As previously mentioned by Lee et al (19), the major limitation of vNOTES is the inability to overview the
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pelvic area, in particular the vesico-uterine pouch, and thus lesions such as bladder endometriosis or anterior
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uterine wall myomas can be missed. Innovation of endoscopes is desirable to overcome this limitation and have
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the ability to explore the entire abdominal cavity.
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Further concern is the possibility of performing TVNH after a previous vNOTES procedure. To date, only one
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group of surgeons has reported on repeated vNOTES, performed in two patients 6 and 8 months after previous
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vNOTES (19).
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267 Conclusion
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In this study, TVNH for benign uteri was successfully and safely completed in appropriately selected parous and
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nulliparous patients. We showed this frugally innovative technique to be feasible with only standard reusable
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laparoscopic instruments and a low cost, self-constructed single port device. This technique may potentially be
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applied in a low resource setting. Although this is only a feasibility study on a small number of patients, it is the
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first report to demonstrate that TVNH is possible.
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According to the Cochrane Database the preferred technique to perform a hysterectomy is via conventional
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vaginal surgery. When a vaginal hysterectomy is not possible, a laparoscopic hysterectomy may avoid the need
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for an abdominal hysterectomy (13). Vaginal hysterectomy can be safely performed for large uteri (20) and in
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nulliparous women (10). The risk of complications however is higher in nulliparous women (10). The
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accessibility of the vaginal passage, disease confined to the uterus, and the surgeons experience are the major
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determining factors for the choice of route of hysterectomies (21). Over the last years, the incidence of robotic
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hysterectomy and laparoscopic hysterectomy has increased and the incidence of vaginal and abdominal
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hysterectomy has decreased (22). Conventional vaginal hysterectomy can be challenging in cases of enlarged
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uterus, undescensus, or because of restricted vaginal space in women who have never delivered (7). Making use
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of the advantages of endoscopic surgery TVNH broadens the indications for vaginal hysterectomy and helps
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overcome its limitations, while the NOTES approach avoids abdominal wall wounds and trocar related
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complications.
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When compared to classical vaginal hysterectomy, NOTES hysterectomy offers good endoscopic visibility to
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operate and perform haemostasis. Using the enlarged endoscopic view, the surgeon can operate accurately using
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endoscopic instruments, whereas in some conditions in conventional vaginal hysterectomy, certain steps can
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ACCEPTED MANUSCRIPT only be achieved by palpation (7). In addition, adnexal procedures in conventional vaginal surgery can be
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difficult due to limited accessibility in the restricted space (7). Salpingectomy, oophorectomy, ovarian
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cystectomy or adhaesiolysis can be performed via the same NOTES approach after a TVNH (11,18). Due to the
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pneumovagina, TVNH is not more difficult in nulliparous than in parous women, whereas a narrow vaginal
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access can make a classical vaginal hysterectomy more challenging (7,10,21)
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When compared to laparoscopic hysterectomy, TVNH offers the advantage of no visible scars. In addition, in
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patients with previous abdominal surgery (e.g. patient 8), there is no need to perform adhaesiolysis to gain access
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to the pelvis in order to perform the hysterectomy via TVNH approach, contrary to a laparoscopic approach.
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NOTES hysterectomy (TVNH and VANH) can provide surgeons the comfort of operating under good
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endoscopic vision but via vaginal access without increasing the invasiveness of the procedure by making
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abdominal incisions.
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When compared to robotic hysterectomy, TVNH offers the same advantages as mentioned in the comparison
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with laparoscopic hysterectomy. In addition, the cost of a robotic hysterectomy is higher than a Poor Man’s
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NOTES TVNH. Further developments in robotic equipment in the future could be helpful to improve the
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ergonomics of NOTES surgery.
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Failure of VANH is almost always due to impedance of the transvaginal colpotomy (7). When compared to
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VANH, TVNH enables the surgeon to perform the colpotomy endoscopically instead of via classical vaginal
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surgery. This provides better visualisation and, as in laparoscopic surgery, the CO2 pressure helps identify and
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dissect the surgical planes. This enabled us to easily perform the anterior and posterior colpotomy in patients
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who had not delivered vaginally and in patients with previous caesarean sections.
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Less post-operative pain and a quicker recovery are also potential advantages of vNOTES. The major limitation
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of vNOTES with the currently available instruments and endoscopes appears to be the inability to explore the
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vesico-uterine pouch. Innovations in instruments and endoscopes will help overcome this limitation.
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A surgeon who wants to perform TVNH should be confident in both classical vaginal hysterectomy and total
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laparoscopic hysterectomy (TLH). Being experienced in single incision laparoscopic surgery TLH and vNOTES
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for adnexal surgery certainly helps to keep the learning curve short. In our experience introduction of NOTES
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into the hysterectomy armamentarium did not influence the percentage of hysterectomies performed by classical
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vaginal hysterectomy, but reduced the percentage of TLH in favour of the less invasive NOTES approach.
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TVNH is a novel approach that requires further validation.
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Acknowledgment
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None.
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Conflict of interest
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Jan Baekelandt declares that he has no conflict of interest.
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Contributions
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Jan Baekelandt recruited and operated all the patients. He collected the data, performed the literature review,
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wrote and submitted the article, and made the video.
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ACCEPTED MANUSCRIPT 333
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15. Peak J, Kim SW, Lee SH et al. Learning curve and surgical outcome for single-port access total laparoscopic
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hysterectomy in 100 consecutive cases. Gynecol Obstet Invest. 2011;72:227-233.
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16. Phongnarisorn C, Chinthakanan O. Transumbilical single-incision laparoscopic hysterectomy with
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conventional laparosopic instruments in patients with symptomatic leiomyoma and/or adenomysosis. Arch
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Gynecol Obstet. 2011;284:893-900.
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17. Zornig C, Mofid H, Siemssen L, et al. Transvaginal NOTES hybrid cholecystectomy: feasibility results in 68
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cases with mid-term follow-up. Endoscopy. 2009;41:391–394.
372
18. Lee CL, Wu KY, Su H, Ueng SH, Yen CH. Transvaginal Natural-Orifice Transluminal Endoscopic Surgery
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(NOTES) in Adnexal Procedures. JMIG. 2012;19:509–513.
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19. Perretta S, Vix M, Dallemagne B, Nassif J, Donatelli G, Marescauw J. Repeated transvaginal notes: is it
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possible? Surg Endosc. 2012;26:565.
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20. Hwang JL, Seow KM, Tsai YL, et al. Comparative study of vaginal, laparoscopically assisted vaginal and
377
abdominal hysterectomy for uterine myoma larger than 6cm in diameter or uterus weighing at least 450g. Acta
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Obstet Gynecol Scand. 2002;81:1132-1138.
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21. Chakraborty S, Goswami S, Mukherjee P, Sau M. Hysterectomy…..Which route? J Obstet Gynaecol
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India.2011;61(5):554-557.
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22. Wasson MN, Hoffman HK. Impact of robotic surgical system on hysterectomy trends. Del Med J.
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2015;87(2):45-50.
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ACCEPTED MANUSCRIPT Figure legends Figure 1 Low cost self-constructed single port device for TVNH, used in nulliparous women.
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Figure 2 Low cost self-constructed single port device for TVNH, used in parous women.
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Range 34 - 61 19.7 – 33.3 60 - 120 0.5 – 2.4
2.5 1.7
1–6 1–2
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Data Age (years) BMI (kg/m2) Total operating time (min) Serum hemoglobine drop (g/dl) Postoperative pain score 6h 24h
1
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Table 2 Patient and perioperative data
33.3
Parity
A1P1G2
History of vaginal delivery yes
Previous pelvic surgery
Indication
AE EUG
menorrhagia menorrhagia
2
46
24.8
A0P1G1
no
LLETZ CS
3
61
22.1
A0P3G3
yes
-
Ovarian cyst
AE
PMB
4
61
24.7
A0P0G0
no
Type of surgery
Port Type
TVNH
LMA
TVNH TVNH+BSO
LMA
TVNH+BSO
Wound Protector
cervical dysplasia
TVNH
5
34
23.8
A1P2G3
yes
LLETZ
6
36
20.3
A0P0G0
no
LLETZ LS endometriosis adhaesiolysis
dysmenorrhea
TVNH
7
45
23.7
A0P0G0
no
-
myomatous uterus
TVNH
52
31.6
A0P1G1
yes
9
52
19.7
A0P3G3
no
10
51
26.4
A0P1G1
yes
Total operating time (min) 120
LMA
(Peri-) operative complications
Specimen Weight (grams)
cystitis
83 126
Postoperative pain score 6h
24h
2
1
2
2
115
1.5
3cm vault haematoma
105
1.5
-
224
2
2
-
107
2
2
1
1
3
2
2
1
6
2
3
2
2
2
120
1.9
65
1.0
-
110
1.8
-
115
2.0
-
39
Wound Protector
Hemicolectomy USO CS x 3 LLETZ AE
adenomyosis cervical dysplasia
-
myomatous uterus
TVNH+USO
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Wound Protector
Serum hemoglobine drop (g/dl) 0.7
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BMI (kg/m2)
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Age (years)
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Patient no.
TVNH
TVNH+USO
Wound Protector LMA
Wound Protector LMA
70
0.5
-
60
1.5
-
90
2.4
-
51 353 62
55 223
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AE = appendectomy; EUG = laparoscopic salpingectomy for ectopic pregnancy; CS = caesarean section; LLETZ = large loop excision of transformation zone; LS = laparoscopic sterilisation; endometriosis = laparoscopy for pelvic endometriosis; adhaesiolysis = laparoscopy for adhaesiolysis; USO = unilateral salpingo-oophorectomy; TVNH= total vaginal NOTES hysterectomy; BSO= bilateral salpingo-oophorectomy; LMA= self-constructed NOTES port using laryngeal mask airway ; PMB = persistent postmenopausal bleeding
ACCEPTED MANUSCRIPT Table 3 Types of Hysterectomy
VH
LAVH
TLH
Name Vaginal Hysterectomy
Laparoscopic Assisted Vaginal Hysterectomy
Total Laparoscopic Hysterectomy
Vaginally Assisted NOTES Hysterectomy
TVNH
Total Vaginal NOTES Hysterectomy
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VANH
Description Total hysterectomy performed entirely through vaginal access under direct vision using conventional surgical instruments Total hysterectomy where first the cranial part of the uterus is dissected via transabdominal laparoscopy and afterwards the caudal part of the uterus is dissected under direct vision using conventional instruments. Total hysterectomy where the entire uterus is dissected via transabdominal laparoscopy Total hysterectomy where first the caudal part of the uterus is dissected vaginally under direct vision and afterwards the rest of the hysterectomy is performed via transvaginal NOTES using an endoscopic camera and endoscopic instruments Total hysterectomy where the entire uterus is dissected via transvaginal NOTES using an endoscopic camera and endoscopic instruments
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Abbreviation
1
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http://www.AAGL.org/jmig-22-5-JMIG-D-15-00150
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This feasibility study reports on the first 10 cases of Total Vaginal NOTES Hysterectomy.
S1553-4650(15)00415-X
DOI:
10.1016/j.jmig.2015.05.015
Reference:
JMIG 2579
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 5 March 2015 Revised Date:
18 May 2015
Accepted Date: 20 May 2015
Please cite this article as: Baekelandt J, Total Vaginal NOTES Hysterectomy (TVNH):A new approach to hysterectomy via Natural Orifice Transluminal Endoscopic Surgery, The Journal of Minimally Invasive Gynecology (2015), doi: 10.1016/j.jmig.2015.05.015. 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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Total Vaginal NOTES Hysterectomy (TVNH):
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A new approach to hysterectomy via Natural Orifice Transluminal Endoscopic Surgery
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Jan Baekelandt
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Department of Obstetrics and Gynaecology, Imelda Hospital Bonheiden, Belgium
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Corresponding author contact information Jan Baekelandt AZ Imelda Hospital Imeldalaan 9, 2820 Bonheiden, Belgium Email: [email protected] Phone: +3215/50 61 89 Fax: +3215/50 59 29
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Keywords
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Transvaginal - NOTES - hysterectomy - frugal innovation - standard reusable instruments - low cost single port
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device - TVNH - VANH - VAMIS - vNOTES
ACCEPTED MANUSCRIPT 51 Abstract
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The aim of this study was to demonstrate the feasibility of a total hysterectomy performed entirely by
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transvaginal natural orifice transluminal endoscopic surgery (vNOTES). Conventional, reusable laparoscopic
57
instruments were used, inserted through an inexpensive, self-constructed single port device.
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Ten Total Vaginal NOTES Hysterectomies (TVNH) were performed by a single surgeon (BJ). The self-
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constructed single port device was made by assembling a surgical glove, a wound protector or modified
60
laryngeal mask airway, one reusable 10 mm trocar, and four reusable 5 mm trocars. This gloveport was inserted
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into the vagina to create a pneumovagina. The conventional steps of a vaginal hysterectomy were followed, but
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performed endoscopically with standard reusable endoscopic instruments. Patient and perioperative data were
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analysed.
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No conversion to standard laparoscopy or laparotomy was necessary in any of the ten patients who underwent a
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TVNH. Mean operation time was 97 min (60-120 min); mean drop in haemoglobin level was 1.5 g/dl ( 0.5-2.4
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g/dl). There were no operative complications, and post-operative pain scores were very low.
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This first report on a small number of patients demonstrates that TVNH is possible. Incorporating the advantages
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of endoscopic surgery it broadens the indications for vaginal hysterectomy and helps overcome its limitations.
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Simultaneously the NOTES approach avoids abdominal wall wounds and trocar related complications. TVNH is
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feasible, even when performed with reusable, conventional laparoscopic instruments. This frugally innovative
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technique also enables surgeons to perform hysterectomies by vNOTES in low resource settings.
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Introduction
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Aiming to reduce surgical morbidity, the evolution from laparotomy to laparoscopy has now broadened to
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include even less invasive techniques, such as single incision laparoscopic surgery (SILS), and natural orifice
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transluminal endoscopy (NOTES). Minimally invasive surgery not only improves cosmetic outcome, but also
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reduces surgical injury. This in turn decreases the inflammatory and neuroendocrine response resulting in less
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post-operative pain and quicker recovery (1, 2).
ACCEPTED MANUSCRIPT NOTES reaches the abdominal cavity by scar-free means, i.e. numerous surgical procedures are performed via a
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natural body orifice. This technique has gained popularity amongst general surgeons, gynaecologists, urologists
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and gastroenterologists over the past few years and its feasibility and safety have been approved (3).
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NOTES can be performed via a variety of approaches including stomach, oesophagus, bladder, and rectum, but
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the majority of NOTES procedures have been performed transvaginally (4). The vagina can be easily
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decontaminated and provides direct access. Culdotomy has been used widely for several surgical procedures (not
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only by gynaecologists but also by general surgeons for extraction of large specimens) and it has been approved
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as safe and easy to close (5).
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In hybrid NOTES the surgical procedure is performed through a natural body orifice with transabdominal
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assistance. The term pure NOTES refers to procedures that involve only transluminal access.
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Given its potential benefits, including scarless intervention, fewer port-related complications, and less painful
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and faster post-operative recovery, transvaginal pure NOTES (vNOTES) for benign adnexal masses was
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introduced into our surgical practice in November 2013. After one year experience with vNOTES for adnexal
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surgery, the feasibility of performing a total hysterectomy entirely via vNOTES was assessed. Hysterectomy via
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NOTES, after performing an anterior and posterior colpotomy and transsecting the sacro-uterine ligaments via
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classical open vaginal surgery, has been described (6,7). We refer to this technique as vaginally assisted NOTES
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hysterectomy (VANH) as the first part of this procedure is performed by conventional vaginal surgery. Despite
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experience in vaginal surgery (BJ is gynaecological oncological surgeon, experienced in Schauta surgery (8,9)),
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it is suggested that, for most gynaecological surgeons, it can be challenging to perform an anterior and posterior
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colpotomy, and transsect the sacro-uterine ligaments (as required for VANH) in patients without any uterine
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prolapse or in patients with a narrow vagina (7). In addition, the complication rate for vaginal hysterectomy is
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higher in nulliparous women than in parous women (10). We therefore wanted to evaluate the feasibility of
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performing a total vaginal NOTES hysterectomy (TVNH), where the entire procedure is performed via vNOTES
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using endoscopic instruments. Our initial clinical experience with TVNH is described here. A full Poor Man’s
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NOTES approach was used (11). The feasibility and surgical outcome of TVNH when performed with only
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conventional, reusable laparoscopic instruments, and an inexpensive, self-constructed single port device that can
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be quickly and easily assembled, was evaluated. We aimed to demonstrate the possibility of performing a TVNH
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and that it is not necessary to use expensive, commercially available disposable SILS-ports, other disposable
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instruments, or sealing devices, to perform a total hysterectomy completely by vNOTES.
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Materials and methods
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Patients
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A single surgeon (BJ) performed 10 TVNH’s to evaluate the feasibility of the technique. To assess if a
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pneumovagina could be maintained in parous and nulliparous women,
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vaginally and 5 patients who had delivered vaginally were selected. All patients were selected for hysterectomy
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due to benign gynaecological disease. Patients were selected based on the following criteria: no contraindication
116
for general anaesthesia, pneumoperitoneum or Trendelenburg position; no fixed uterus, strong pelvic adhesions
117
or nodularity in the Pouch of Douglas on clinical examination; no history of pelvic inflammatory disease; no
118
suspicion for malignancy. Obesity (BMI > 30) was not considered to be an exclusion criteria.
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The following patient and perioperative data were collected and retrospectively analysed: patient age, body mass
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index (BMI), parity, history of vaginal delivery, previous pelvic surgery, type of surgery, total operating time,
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serum hemoglobin (Hb) drop (change between the preoperative Hb and postoperative Hb one day after surgery),
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peri-operative complications, and postoperative pain score.
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The duration of surgery was defined as the time from the placement of the Foley catheter to the end of vaginal
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closure. Bowel, bladder, ureteral or vascular injuries, as well as blood loss > 300 ml were considered as
125
intraoperative complications. Short-term postoperative complications were identified to be urinary tract
126
infection, postoperative ileus, vaginal vault bleeding or infection, or hematuria.
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Postoperative pain was assessed using the visual analogue pain scale (VAS) (scoring from 0 = no pain, to 10 =
128
worst imaginable pain). The VAS score was evaluated at 6 and 24 hours postoperatively. All patients received
129
the same intraoperative analgesia: intravenous paracetamol 1000 mg and ketorolac trometamol 20 mg.
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Postoperative pain was managed by paracetamol 1000 mg and ketorolac trometamol was administered on
131
patient’s demand.
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Prophylactic intravenous antibiotic therapy, cefazoline 2 g and metronidazol 500 mg, was administrated during
133
surgery.
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No vaginal intercourse was allowed for 6 weeks after the procedure. Each patient was re-assessed at the post-
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operative consultation 6 weeks after surgery.
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5 patients who had not delivered
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Surgical technique
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The patient was placed in lithotomy position under general anaesthesia.
139
performed to exclude pelvic adhesions or obliteration of the Pouch of Douglas.
A rectovaginal examination was
ACCEPTED MANUSCRIPT Construction of the low cost NOTES port:
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For the five patients who had not delivered vaginally, an Alexis Wound Protector/Retractor (Applied Medical,
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Rancho Santa Margarita, CA, USA) attached to a size 8 surgical glove was used. One finger of the surgical
143
glove was incised to place a 10 mm reusable trocar for CO2 insufflation and laparoscope insertion. Four 5 mm
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reusable trocars were placed through the remaining fingers for insertion of the reusable laparoscopic instruments
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(Figure 1). In nulliparous women the ring of the wound protector holds the gloveport in the vagina during the
146
procedure. CO2 insufflation at 15mmHg does not dislodge the port.
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For the five patients who had delivered vaginally, the same glove construction was used, but it was attached to
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an opened size 5 laryngeal mask airway (LMA) instead of a wound protector. The central part of the LMA was
149
excised, leaving only the outer rim and inflatable cushion. The wrist side of the glove (with trocars in the fingers)
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was passed through the opening of the LMA and folded around the cushion part of the LMA (Figure 2). After
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inserting the LMA into the vagina, the cushion part was inflated and an orthostatic wound protector was placed
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in the LMA to hold it in place in the vagina. Tightening the orthostatic wound protector fixes the LMA in the
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caudal part of the vagina and prevents the CO2 insufflation from pushing the vaginal port out of the vagina.
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154 Endoscopic equipment:
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We used a standard rigid zero-degree 10 mm laparoscope. Only reusable conventional laparoscopic instruments
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were used: a bipolar forceps, a pair of cold scissors, a grasping forceps (Manhes), a monopolar hook, and a
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suction-irrigation cannula. No disposable instruments or sealing devices were used.
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Procedure description (Video 1)
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The operation field was disinfected and draped. A Foley catheter was placed and the self-constructed NOTES
162
port was placed into the vagina. CO2 was insufflated at 15 mmHg to maintain an adequate pneumovagina.
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With traction placed on the uterine cervix using the Manhes forceps the cervix was circumcised using the
164
monopolar hook. At the anterior fornix the vaginal mucosa and the bladder were pushed up along the uterine-
165
cervical fascia using a small swab in the atraumatic grasper, while maintaining traction on the cervix using the
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Manhes forceps. Once the peritoneum between the bladder and the uterus could be identified, it was opened
167
using cold scissors. The same technique was used in the posterior fornix until the peritoneum of the Pouch of
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Douglas could be visualised and opened.
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ACCEPTED MANUSCRIPT Once the anterior and posterior peritoneum were opened, both sacro-uterine ligaments were coagulated using the
170
bipolar forceps and subsequently transsected using the cold scissors. After identification of both ureters, this
171
procedure was repeated, caudally to cranially, for the remainder of the parametrium, the uterine arteries and the
172
ovarian ligament, and Fallopian tube. In patients where a bilateral adnexectomy was performed, the
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infundibulopelvic ligament was transsected instead of the ovarian ligament and Fallopian tube. One patient had
174
an 8 cm ovarian cyst. In this case the infundibulopelvic ligament was transsected after having first transsected
175
the ovarian ligament and Fallopian tube to place the free uterus in the upper abdomen, thus allowing space to
176
perform the adnexectomy.
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In patients with a small uterus, the entire procedure was performed with the NOTES port in the vaginal introitus.
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In patients with a larger uterus, the NOTES port was moved up from the introitus into the Pouch of Douglas after
179
transsecting the sacro-uterine ligaments. This significantly improved visualisation.
180
After haemostasis and rinsing of the peritoneal cavity, the pneumoperitoneum was deflated and the port device
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was removed. The uterus (and adnexae) were extracted and the colpotomy was closed using a Vicryl-1 (Ethicon,
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Piscataway, NJ, USA) suture.
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183 Results
185
Ten TVNH’s were successfully performed by Poor Man’s tNOTES using conventional, reusable laparoscopic
186
instruments. No conversion to standard multi incision laparoscopy or laparotomy was necessary. In four patients
187
one or both adnexae were also removed; one of them had an 8 cm mucinous cystadenoma.
188
Table 1 presents an overview of patient and perioperative data. Individual patient details are presented in Table
189
2. Mean operation time was 97 minutes. Five patients had had previous pelvic surgery. There were no
190
intraoperative complications. One patient had a postoperative cystitis for which oral antibiotic therapy was
191
administered; and one patient had a small vault haematoma that was managed conservatively under antibiotic
192
cover. The mean drop in hemoglobin level was 1.5 g/dl. Most patients scored a low postoperative pain score
193
(range 1-2) 24 hours after surgery. All uteri were benign upon pathological examination (specimen weight 51-
194
353g).
195
As these were the first 10 patients to be operated by a new surgical technique, we requested all patients to remain
196
hospitalised for 72 hours for comprehensive follow up. Each patient was examined six weeks after surgery.
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There was no vaginal wound infection nor dehiscence, and none of the patients complained of pain during
198
pelvic examination. All patients were in good health and were back at work.
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ACCEPTED MANUSCRIPT 199 Discussion
201
In this feasibility study, TVNH for benign uteri was successfully performed in ten patients, using only
202
conventional, reusable laparoscopic instruments and a self-constructed NOTES port. The procedures were
203
completed within a reasonable operation time and without major complications, no conversion to laparotomy or
204
standard laparoscopy was necessary. We demonstrated that this technique can be used in parous and nulliparous
205
women, provided that a different port is constructed to maintain a pneumovagina.
206
To the best of our knowledge this is the first report of TVNH being successfully performed on patients. A
207
PubMed search revealed that a cadaveric model for hysterectomy by Vaginal Access Minimally Invasive
208
Surgery (VAMIS) has recently been presented (12). The major difference between TVNH and a VANH lies in
209
the opening of the anterior and posterior peritoneum and the transsection of the sacro-uterine ligaments. This is
210
performed entirely endoscopically in the TVNH, whereas it is performed by classical vaginal surgery in a VANH
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(Table 3). The TVNH technique can therefore also be used in nulliparous patients, patients without uterine
212
prolapse, and patients with a narrow vagina where classical vaginal surgery can be more challenging (7,10).
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An inexpensive, self-constructed single port device, that can be quickly and easily made, was used. By
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combining this self-constructed port device with easily available, conventional, and reusable laparoscopic
216
instruments, this study shows that the TVNH technique is feasible without increasing the cost of laparoscopic
217
surgery. This frugally innovative technique can thus potentially be performed in a low resource setting. Poor
218
Man’s vNOTES has previously been described as an approach for adhaesiolysis (11).
219
A self-constructed port using a surgical glove has advantages when compared to commercial ports. It is less
220
costly, it has flexible material that enables greater manipulation of instruments, and a greater number and size of
221
instruments can be passed through the incision. Multiple instruments can therefore be left in place in the trocars
222
limiting the number of instrument changes and port transfers. In our experience constructing a Poor Man’s
223
NOTES port takes approximately 3 minutes for a gloveport with wound protector and approximately 5 minutes
224
for a gloveport with LMA. It is constructed by the first assistant while the surgeon disinfects and drapes the
225
patient and therefore does not add to the total operation room time.
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Conventional transvaginal surgery has the advantage of the absence of abdominal scarring and is the preferential
228
approach to hysterectomy (13). By performing vNOTES, the technical drawbacks of transvaginal surgery,
ACCEPTED MANUSCRIPT including limited visualisation to attempt good hemostasis and difficulty in performing adnexectomy in case of
230
adhesions between the adnexa and the uterus, can be overcome. Additionally, vNOTES eliminates the risk of
231
trocar related complications and induces less post-operative pain (14). It has been demonstrated that very large
232
uteri can be removed via VANH, and that ligating the uterine vessels transvaginally before dissecting the rest of
233
the uterus, results in less blood loss compared to a transabdominal laparoscopic approach where there is more
234
manipulation before occlusion of the feeding vessels (6,7). This still needs to be demonstrated in further studies
235
for TVNH but as the second part of the procedure is identical to VANH, the same advantage can be expected.
236
TVNH also enables the removal of uteri when the cervix is less accessible for classical vaginal surgery or
237
VANH.
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To perform vNOTES various technical difficulties, comparable to those for transumbilical SILS, need to be
240
overcome. The surgeon has to deal with problems due to instrument collision, limited triangulation, and reduced
241
traction of tissue (15, 16). Due to the vagina providing a more flexible entry point compared to the infra-
242
umbilical fascia opening, these difficulties were found to be less restricting when compared with SILS. Further
243
advances in optics, instruments and robotic surgery will help overcome these technical challenges, enabling
244
more surgeons to perform more hysterectomies via transvaginal access.
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One could argue the possibility of pelvic infection after vaginal surgery, however none of our patients presented
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with this complication after the TVNH procedure. Previous studies have also shown that post-operative pelvic
248
infection is unlikely to happen particularly when prophylactic antibiotics are administered (7, 17). As the vaginal
249
vault is closed in the same way as in a classical vaginal hysterectomy, no differences in incidence of dyspareunia
250
are to be expected. As was the case for our study protocol, sexual abstinence should be recommended for six to
251
eight weeks, as is the recommendation for conventional transvaginal surgery (7).
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The same contra-indications should be considered before performing TVNH as before performing vNOTES. In
254
patients with a massive hemoperitoneum the endoscopic view will get disturbed (18). If Pouch of Douglas
255
adhesions can be expected, a thorough pelvic examination should be performed prior to surgery, and in case of
256
unexpected Pouch of Douglas obliteration, conversion to transabdominal laparoscopy should be considered.
257
Virginity is another contra-indication for vNOTES. Nulliparity or absence of history of vaginal delivery are not
258
contra-indications to perform vNOTES.
ACCEPTED MANUSCRIPT 259 As previously mentioned by Lee et al (19), the major limitation of vNOTES is the inability to overview the
261
pelvic area, in particular the vesico-uterine pouch, and thus lesions such as bladder endometriosis or anterior
262
uterine wall myomas can be missed. Innovation of endoscopes is desirable to overcome this limitation and have
263
the ability to explore the entire abdominal cavity.
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Further concern is the possibility of performing TVNH after a previous vNOTES procedure. To date, only one
265
group of surgeons has reported on repeated vNOTES, performed in two patients 6 and 8 months after previous
266
vNOTES (19).
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267 Conclusion
269
In this study, TVNH for benign uteri was successfully and safely completed in appropriately selected parous and
270
nulliparous patients. We showed this frugally innovative technique to be feasible with only standard reusable
271
laparoscopic instruments and a low cost, self-constructed single port device. This technique may potentially be
272
applied in a low resource setting. Although this is only a feasibility study on a small number of patients, it is the
273
first report to demonstrate that TVNH is possible.
274
According to the Cochrane Database the preferred technique to perform a hysterectomy is via conventional
275
vaginal surgery. When a vaginal hysterectomy is not possible, a laparoscopic hysterectomy may avoid the need
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for an abdominal hysterectomy (13). Vaginal hysterectomy can be safely performed for large uteri (20) and in
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nulliparous women (10). The risk of complications however is higher in nulliparous women (10). The
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accessibility of the vaginal passage, disease confined to the uterus, and the surgeons experience are the major
279
determining factors for the choice of route of hysterectomies (21). Over the last years, the incidence of robotic
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hysterectomy and laparoscopic hysterectomy has increased and the incidence of vaginal and abdominal
281
hysterectomy has decreased (22). Conventional vaginal hysterectomy can be challenging in cases of enlarged
282
uterus, undescensus, or because of restricted vaginal space in women who have never delivered (7). Making use
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of the advantages of endoscopic surgery TVNH broadens the indications for vaginal hysterectomy and helps
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overcome its limitations, while the NOTES approach avoids abdominal wall wounds and trocar related
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complications.
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When compared to classical vaginal hysterectomy, NOTES hysterectomy offers good endoscopic visibility to
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operate and perform haemostasis. Using the enlarged endoscopic view, the surgeon can operate accurately using
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endoscopic instruments, whereas in some conditions in conventional vaginal hysterectomy, certain steps can
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difficult due to limited accessibility in the restricted space (7). Salpingectomy, oophorectomy, ovarian
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cystectomy or adhaesiolysis can be performed via the same NOTES approach after a TVNH (11,18). Due to the
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pneumovagina, TVNH is not more difficult in nulliparous than in parous women, whereas a narrow vaginal
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access can make a classical vaginal hysterectomy more challenging (7,10,21)
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When compared to laparoscopic hysterectomy, TVNH offers the advantage of no visible scars. In addition, in
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patients with previous abdominal surgery (e.g. patient 8), there is no need to perform adhaesiolysis to gain access
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to the pelvis in order to perform the hysterectomy via TVNH approach, contrary to a laparoscopic approach.
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NOTES hysterectomy (TVNH and VANH) can provide surgeons the comfort of operating under good
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endoscopic vision but via vaginal access without increasing the invasiveness of the procedure by making
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abdominal incisions.
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When compared to robotic hysterectomy, TVNH offers the same advantages as mentioned in the comparison
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with laparoscopic hysterectomy. In addition, the cost of a robotic hysterectomy is higher than a Poor Man’s
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NOTES TVNH. Further developments in robotic equipment in the future could be helpful to improve the
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ergonomics of NOTES surgery.
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Failure of VANH is almost always due to impedance of the transvaginal colpotomy (7). When compared to
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VANH, TVNH enables the surgeon to perform the colpotomy endoscopically instead of via classical vaginal
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surgery. This provides better visualisation and, as in laparoscopic surgery, the CO2 pressure helps identify and
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dissect the surgical planes. This enabled us to easily perform the anterior and posterior colpotomy in patients
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who had not delivered vaginally and in patients with previous caesarean sections.
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Less post-operative pain and a quicker recovery are also potential advantages of vNOTES. The major limitation
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of vNOTES with the currently available instruments and endoscopes appears to be the inability to explore the
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vesico-uterine pouch. Innovations in instruments and endoscopes will help overcome this limitation.
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A surgeon who wants to perform TVNH should be confident in both classical vaginal hysterectomy and total
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laparoscopic hysterectomy (TLH). Being experienced in single incision laparoscopic surgery TLH and vNOTES
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for adnexal surgery certainly helps to keep the learning curve short. In our experience introduction of NOTES
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into the hysterectomy armamentarium did not influence the percentage of hysterectomies performed by classical
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vaginal hysterectomy, but reduced the percentage of TLH in favour of the less invasive NOTES approach.
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TVNH is a novel approach that requires further validation.
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Acknowledgment
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None.
322 323 324
Conflict of interest
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Jan Baekelandt declares that he has no conflict of interest.
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Contributions
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Jan Baekelandt recruited and operated all the patients. He collected the data, performed the literature review,
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wrote and submitted the article, and made the video.
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References
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endoscopic surgery (NOTES): a series of 137 patients. J Minim Invasive Gynecol. 2014;21(5):814-24.
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8.Dargent D. Laparoscopic assisted vaginal radical hysterectomy – evolution of a concept. CME Journal of
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Gynecologic Oncology. Chapter 9:102-109.
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hysterectomy in the treatment of cervical cancer: a retrospective analysis. Am J Obstet Gynecol. 1993;168(3 Pt
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Video Demonstration. J Minim Invasive Gynecol. 2014 Nov 10. Pii: S1553-4650(14)01530-1.doi:
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10.1016/j.jmig.2014.11.001. (Epub ahead of print)12. Vaginal Access Minimally Invasive Surgery: A new
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13. Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, et al. Surgical approach to hysterectomy
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ACCEPTED MANUSCRIPT 14. Hackethal A, Sucke J, Oehmke F, et al. Establishing transvaginal NOTES for gynecological and surgical
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indications: benefits, limits, and patient experience. Endoscopy. 2010;42:875–878.
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15. Peak J, Kim SW, Lee SH et al. Learning curve and surgical outcome for single-port access total laparoscopic
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ACCEPTED MANUSCRIPT Figure legends Figure 1 Low cost self-constructed single port device for TVNH, used in nulliparous women.
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Figure 2 Low cost self-constructed single port device for TVNH, used in parous women.
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ACCEPTED MANUSCRIPT Table 1 Overview of patient and perioperative characteristics Mean 48.4 25.1 97 1.5
Range 34 - 61 19.7 – 33.3 60 - 120 0.5 – 2.4
2.5 1.7
1–6 1–2
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Data Age (years) BMI (kg/m2) Total operating time (min) Serum hemoglobine drop (g/dl) Postoperative pain score 6h 24h
1
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Table 2 Patient and perioperative data
33.3
Parity
A1P1G2
History of vaginal delivery yes
Previous pelvic surgery
Indication
AE EUG
menorrhagia menorrhagia
2
46
24.8
A0P1G1
no
LLETZ CS
3
61
22.1
A0P3G3
yes
-
Ovarian cyst
AE
PMB
4
61
24.7
A0P0G0
no
Type of surgery
Port Type
TVNH
LMA
TVNH TVNH+BSO
LMA
TVNH+BSO
Wound Protector
cervical dysplasia
TVNH
5
34
23.8
A1P2G3
yes
LLETZ
6
36
20.3
A0P0G0
no
LLETZ LS endometriosis adhaesiolysis
dysmenorrhea
TVNH
7
45
23.7
A0P0G0
no
-
myomatous uterus
TVNH
52
31.6
A0P1G1
yes
9
52
19.7
A0P3G3
no
10
51
26.4
A0P1G1
yes
Total operating time (min) 120
LMA
(Peri-) operative complications
Specimen Weight (grams)
cystitis
83 126
Postoperative pain score 6h
24h
2
1
2
2
115
1.5
3cm vault haematoma
105
1.5
-
224
2
2
-
107
2
2
1
1
3
2
2
1
6
2
3
2
2
2
120
1.9
65
1.0
-
110
1.8
-
115
2.0
-
39
Wound Protector
Hemicolectomy USO CS x 3 LLETZ AE
adenomyosis cervical dysplasia
-
myomatous uterus
TVNH+USO
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Wound Protector
Serum hemoglobine drop (g/dl) 0.7
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BMI (kg/m2)
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Age (years)
M AN U
Patient no.
TVNH
TVNH+USO
Wound Protector LMA
Wound Protector LMA
70
0.5
-
60
1.5
-
90
2.4
-
51 353 62
55 223
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AE = appendectomy; EUG = laparoscopic salpingectomy for ectopic pregnancy; CS = caesarean section; LLETZ = large loop excision of transformation zone; LS = laparoscopic sterilisation; endometriosis = laparoscopy for pelvic endometriosis; adhaesiolysis = laparoscopy for adhaesiolysis; USO = unilateral salpingo-oophorectomy; TVNH= total vaginal NOTES hysterectomy; BSO= bilateral salpingo-oophorectomy; LMA= self-constructed NOTES port using laryngeal mask airway ; PMB = persistent postmenopausal bleeding
ACCEPTED MANUSCRIPT Table 3 Types of Hysterectomy
VH
LAVH
TLH
Name Vaginal Hysterectomy
Laparoscopic Assisted Vaginal Hysterectomy
Total Laparoscopic Hysterectomy
Vaginally Assisted NOTES Hysterectomy
TVNH
Total Vaginal NOTES Hysterectomy
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VANH
Description Total hysterectomy performed entirely through vaginal access under direct vision using conventional surgical instruments Total hysterectomy where first the cranial part of the uterus is dissected via transabdominal laparoscopy and afterwards the caudal part of the uterus is dissected under direct vision using conventional instruments. Total hysterectomy where the entire uterus is dissected via transabdominal laparoscopy Total hysterectomy where first the caudal part of the uterus is dissected vaginally under direct vision and afterwards the rest of the hysterectomy is performed via transvaginal NOTES using an endoscopic camera and endoscopic instruments Total hysterectomy where the entire uterus is dissected via transvaginal NOTES using an endoscopic camera and endoscopic instruments
RI PT
Abbreviation
1
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http://www.AAGL.org/jmig-22-5-JMIG-D-15-00150
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This feasibility study reports on the first 10 cases of Total Vaginal NOTES Hysterectomy.
