Journal of Obstetrics and Gynaecology, January 2014; 34: 65–69 © 2014 Informa UK, Ltd. ISSN 0144-3615 print/ISSN 1364-6893 online DOI: 10.3109/01443615.2013.828685
GYNAECOLOGY
Minilaparotomy vs laparoscopic hysterectomy for benign gynaecological diseases N. Sirisabya & T. Manchana
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Department of Obstetrics and Gynecology, Gynecologic Oncology Division, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Hysterectomy is the most frequent gynaecological procedure carried out with either conventional (abdominal) or minimally invasive surgery (MIS). Despite the advantage of MIS compared with the conventional procedure, it requires extensive training and a long learning curve. Minilaparotomy hysterectomy is an alternative approach that needs no sophisticated and expensive equipment or training. The objective of this study was to compare the perioperative outcomes between minilaparotomy hysterectomy (MH) and laparoscopic hysterectomy (LH) in patients with benign gynaecological diseases. A significantly shorter operative time was obtained in MH. There was no significant difference in blood loss and perioperative complications. However, a higher intraoperative complication (two bladder injuries and one major blood loss) were observed in the LH. Early postoperative VAS pain scores and recovery time were insignificantly different between both groups. Overall patient satisfaction levels and satisfaction scores were found to be similar in both groups, without significant difference. Keywords: Gynaecological disease, hysterectomy, laparoscopy, minilaparotomy, minimally invasive surgery
Introduction Hysterectomy is the most frequent gynaecological procedure, usually for benign gynaecological conditions, such as leiomyoma (Wu et al. 2003; Falcone and Walters 2008). There are three approaches: abdominal, vaginal and laparoscopic hysterectomy. Abdominal hysterectomy is a conventional approach, whereas the two latter techniques are considered as minimally invasive surgery (MIS), with less blood loss, shorter hospital stays, less febrile morbidity or infection and a quicker return to normal activities. Patients’ outcomes are similar between laparoscopic and vaginal hysterectomy, although shorter operative time is reported in vaginal hysterectomy (Nieboer et al. 2009). However, large uterine size, pelvic adhesion from previous abdominal surgery or endometriosis, absence of uterine descent and limited vaginal exposure may constraint its usability. Furthermore, these two MIS techniques require intensive training and a long learning curve. Hence, abdominal hysterectomy remains the most common technique performed by gynaecologists in the USA (Wu et al. 2003). Minilaparotomy hysterectomy is an alternative approach. Surgical technique is similar to the conventional laparotomy, without the need of sophisticated and expensive equipment and lengthy
training. This approach satisfies the criteria of MIS because of a small surgical incision with less postoperative pain. It also has comparable outcomes with respect to laparoscopy in many surgical procedures such as cholecystectomy and tubal sterilisation (Kulier et al. 2004; Purkayastha et al. 2007). Minilaparotomy was also reported to be applicable for hysterectomy, myomectomy, salpingo-oophorectomy, and cystectomy in benign gynaecological diseases (Fanfani et al. 2005). The aim of this study was to compare the perioperative outcomes, including time to return to normal activity, and patient satisfaction between minilaparotomy and laparoscopic hysterectomy.
Materials and methods Patients and operation procedures This retrospective study was conducted in 100 patients undergoing hysterectomy for benign gynaecological conditions, such as leiomyoma, adenomyosis, benign ovarian cyst, cervical intraepithelial neoplasia (CIN) and dysfunctional uterine bleeding (DUB). These patients were operated at the King Chulalongkorn Memorial Hospital between July 2009 and April 2012. All surgical procedures were performed by the two authors. Prophylactic antibiotic (cefazolin 1 g or ceftriaxone 1 g) was given 30 min before operation. If the patients had a history of allergy to cephalosporin, clindamycin 900 mg was administered. The patients were categorised into two groups; laparoscopic hysterectomy (LH) and minilaparotomy hysterectomy (MH). The patients in the LH were performed under general anaesthesia (GA) in the steep lithotomy position. A Foley catheter and uterine manipulator was inserted. The 5 mm laparoscope was introduced under direct visualisation by bladeless trocar (ENDOPATH® XCELTM, Ethicon Endo-Surgery, Cincinnati, OH) at the umbilicus followed by CO2 pneumoperitoneum. The other two 5 mm trocars were inserted at the right and left lower quadrants. The last 5 mm trocar was inserted at the left side of abdomen between the umbilical and left lower quadrant port (Figure 1). After thorough abdominal exploration, the round ligaments were resected and retroperitoneal spaces were opened to identify the ureters. Then, the infundibulopelvic ligaments or the uteroovarian ligaments were excised, depending on whether oophorectomy was planned. All procedures were performed using a Harmonic scalpel (Ethicon Endo-Surgery). The anterior and posterior leafs of the broad ligament were excised and bladder flap was developed. The uterine vessels were sealed and culdotomy was done
Correspondence: T. Manchana, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand. E-mail: [email protected]
66
N. Sirisabya & T. Manchana anaesthesia. A Pfannenstiel incision with the length ⱕ 7 cm was done (Figure 2A). A wound retractor (Alexis®, Applied Medical, Rancho Santa Margarita, CA) was placed to widen the operative field (Figure 2B, C). The surgical steps were performed according to the standard technique. After the uterine vessels were ligated, uterine morcellation with a scalpel was done to reduce the uterine size and the uterus was elevated out of the surgical field (Figure 2D). If an ovarian cyst was larger than the incision, cyst content was aspirated without intraperitoneal contamination. The remaining steps were performed by standard technique. Vaginal cuff closure was done by continuous suture, with delay absorbable suture No.1.
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Data collection and statistical analysis Figure 1. Location of all port sites in laparoscopic hysterectomy group.
from anterior to posterior using a monopolar hook. The uterus was morcellated by a scalpel to reduce uterine size, if it could not be removed vaginally. The vaginal cuff was sutured transvaginally in continuous suture using delay absorbable suture No. 1. Haemostasis was re-evaluated through the laparoscope at the end of the procedure. The patients in the MH were placed in the supine position under spinal anaesthesia, with 0.5% heavy Marcaine, combined with morphine 0.2 mg. However, GA was administered in some patients if they requested or had contraindications for spinal
Intraoperative data included operative time, blood loss, intraoperative complications, uterine size according to gestational weeks, uterine weight, rates of conversion to laparotomy in the LH or conversion to a larger incision in the MH, and length of skin incision for the MH. Postoperative complications were defined as any unfavourable events within the first 30 days after surgery. This included febrile morbidity, which was defined as body temperature ⱖ 38°C in two consecutive measurements at least 6 h apart but excluded the first 24 h. Postoperative pain was evaluated every 6 h on the first and second postoperative day (POD) by visual analogue scale (VAS): 0–10 scores (0 ⫽ no pain; 10 ⫽ worst pain). The worst score in each day was used for analysis. Pain control in the first 24 h in the LH and MH who had GA was intravenous opioid (morphine or pethidine) every 4 h. Spinal anaesthesia
Figure 2. (A) Minilaparotomy hysterectomy with Pfannenstiel incision ⱕ 7 cm. (B) Alexis® (Applied Medical, Rancho Santa Margarita, CA). (C) Alexis® was placed to widen operative field. (D) Uterus was morcellated by scalpel to reduce uterine size.
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Minilaparotomy vs laparoscopic hysterectomy 67 with morphine and rescue doses of intravenous Tramadol 50 mg every 4–6 h were given as the pain control regimen within the first 24 h for the MH. If there were no contraindications, Celecoxib (Celebrex®) 400 mg or Etoricoxib (Arcoxia®) 120 mg were prescribed once daily starting on the second POD and continued for 7 days in both groups. Otherwise, acetaminophen or any nonsteroidal anti-inflammatory drugs (NSAID) were prescribed. The patients were discharged if they ambulated, tolerated soft diet and had no significant complications. The duration of hospital stay was recorded. The time to return to normal activity and patient satisfaction were recorded. Satisfaction was graded as follows: 0 ⫽ very unsatisfied; 1 ⫽ somewhat unsatisfied; 2 ⫽ neither satisfied nor unsatisfied; 3 ⫽ somewhat satisfied; 4 ⫽ very satisfied. Moreover, satisfaction was scored by VAS (0–10 scores). χ2-test or Fisher’s exact test was used to analyse categorical data. Student’s t-test and Mann–Whitney U test was used to compare parametric and non-parametric continuous data, respectively. A p value of ⬍ 0.05 was considered statistically significant.
Results The most common indication for hysterectomy was leiomyoma (62.5%). Other indications were as follows: adenomyosis (16.3%); ovarian tumour (12.5%); CIN3 (3.8%); DUB (1.3%) and others (2.5%). However, there was no difference of indications between both groups. The patients’ characteristics were similar, except for lower parity and larger size of uterus in the MH (Table I). Most patients in the MH were nulliparous. Median length of surgical incision in the MH was 6 cm (range 4–7). There was one patient in the LH (2.4%) that required conversion to abdominal hysterectomy, due to severe pelvic adhesion and major blood loss. This patient had adenomyosis with severe pelvic endometriosis. She also had one previous laparoscopic cystectomy for endometriotic cyst. However, minilaparotomy approach (6 cm of surgical incision) was performed successfully in this patient. In contrast, there was no patient in the MH group who was converted to conventional abdominal hysterectomy. Our study indicated a significantly shorter operative time in MH without a difference in term of blood loss and complications when compared with LH (Table II). Nonetheless, more intraoperative complications were found in LH (two bladder injuries; one major bleeding that required blood transfusion); it did not reach statistical significance however. There was no febrile morbidity, wound infection and wound separation or
vaginal cuff dehiscence in either group. Low early postoperative VAS pain scores were reported in both groups without significant difference. Pain was relieved by oral analgesic drugs in all patients. A significantly shorter hospital stay was reported in the LH group. Mean time to return to normal activity was up to 3 weeks in both groups, without significant difference. Importantly, there was no significant difference in the satisfaction levels and satisfaction scores between both groups, with almost all of the patients indicating satisfied or very satisfied (Table II).
Discussion There is a consensus that hysterectomy by MIS technique is superior to the conventional technique (Falcone and Walters 2008). A Cochrane review showed that vaginal hysterectomy is preferable to abdominal hysterectomy. If this is not feasible, then laparoscopic hysterectomy is the alternative choice (Nieboer et al. 2009). Vaginal hysterectomy has comparable outcomes with laparoscopic hysterectomy, except for a shorter operative time. However, previous caesarean delivery, nulliparity or no prior vaginal delivery, large uterus, lack of uterine descent and planned oophorectomy, are relative contraindications for vaginal hysterectomy (Kulkarni and Rogers 2010). Although, the benefits of vaginal hysterectomy are recognised, many gynaecologists are uncomfortable with this technique. Previous reports showed a decline in the number of vaginal hysterectomies, while the number of laparoscopic hysterectomies has increased (Donnez et al. 2009). Laparoscopic hysterectomy has several reported advantages compared with the conventional abdominal hysterectomy, including reduction in postoperative pain, less blood loss, shorter hospital stay and faster recovery. Nonetheless, its drawbacks are longer operative time, expensive equipment, required special training and a longer learning curve (Hoffman and Lynch 1998). Thus, the benefit of laparoscopic surgery was reported only by experienced surgeons. Moreover, patients with large uterine size, large ovarian cyst, pelvic adhesion, previous pelvic surgery and cardiopulmonary compromise contraindicating for pneumoperitoneum, eliminate their candidacy for laparoscopic surgery. In addition, tumour rupture or spillage of cyst content during laparoscopy is a major concern, especially in an unexpected diagnosis of ovarian cancer. Minilaparotomy may be an alternative MIS technique for hysterectomy, especially in specific conditions such as large uterine
Table I. Patients’ characteristics. Minilaparotomy hysterectomy (n ⫽ 59) n Age (years) (mean ⫾ SD) Parity (median, range) Nulliparous BMI (kg/m2) (mean ⫾ SD) Menopause Previous pelvic surgery Pelvic adhesion Uterine size (gestational weeks) (median, range) Uterine weight (g) (median, range) Size of ovarian tumour (cm) (median, range) BMI, Body mass index.
46.0 ⫾ 7.5 0 (0–4) 35 23.9 ⫾ 4.3 5 9 10 14 (6–24) 309.0 (35–1655.5) 6 (4–12), n ⫽ 8
(%)
59.3 8.5 15.3 16.9
Laparoscopic hysterectomy (n ⫽ 41) n 47.8 ⫾ 7.7 2 (0–4) 15 23.8 ⫾ 3.8 8 13 7 8 (5–14) 164.3 (55.6–522.7) 5 (2–10), n ⫽ 9
(%)
36.6 19.5 31.7 17.1
p value 0.24 0.01 0.01 0.93 0.09 0.08 0.60 ⬍ 0.001 ⬍ 0.001 0.54
68
N. Sirisabya & T. Manchana Table II. Perioperative outcomes and patient satisfaction. Minilaparotomy hysterectomy (n ⫽ 59)
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n Operative time (min) (mean ⫾ SD) Blood loss (ml) (mean ⫾ SD) Conversion rate Postoperative VAS pain scores on the first POD (median, range) Postoperative VAS pain scores on the second POD (median, range) Intraoperative complication Hospital stay (days) (mean ⫾ SD) Time to return to normal activity (days) (mean ⫾ SD) VAS satisfaction scores (mean ⫾ SD) Satisfaction level Very unsatisfied Somewhat unsatisfied Neither satisfied nor unsatisfied Somewhat satisfied Very satisfied
81.9 ⫾ 19.6 250.8 ⫾ 185.3 0 2 (0–10)
(%)
0
1 (0–7) 0 2.9 ⫾ 0.6 21.7 ⫾ 9.3
n 107.4 ⫾ 32.3 215.8 ⫾ 165.2 1 2 (0–7)
(%)
2.4
1 (0–3) 0
9.3 ⫾ 1.0 0 0 1 25 33
Laparoscopic hysterectomy (n ⫽ 41)
3 2.5 ⫾ 1.1 20.1 ⫾ 9.4
0 0 1 15 25
⬍ 0.001 0.45 0.41 0.80 0.06
7.3
9.5 ⫾ 0.8 0 0 1.7 42.4 55.9
p value
0.07 0.02 0.40 0.25 0.83
0 0 2.4 36.6 61.0
VAS, visual analogue scale; POD, postoperative day.
size, pelvic adhesion, previous pelvic surgery and patients with morbid obesity or cardiopulmonary compromise (Hoffman and Lynch 1998; Pelosi and Pelosi 2004; Sharma et al. 2004; Fanfani et al. 2005; Panici et al. 2005; Alcalde et al. 2007). A previous nonrandomised comparative study reported that MH had shorter operative time, less blood loss, shorter hospital stay, faster recovery and fewer complications than the conventional abdominal hysterectomy (Sharma et al. 2004). However, the use of a vertical incision instead of a transverse incision and larger uterine size in the abdominal hysterectomy group, may confound the study’s conclusion. Various comparative studies between laparoscopicassisted vaginal hysterectomy (LAVH) and MH were reported (Muzii et al. 2007; Sesti et al. 2008). Muzii et al. (2007) reported that LAVH had significantly longer operative time, lower early postoperative pain scores, and lower complication rates than MH. In contrast, Sesti et al. (2008) reported no significant difference regarding operative time and complications between MH and LAVH. However, MH had significantly greater blood loss during operation and longer hospital stay. The heterogeneity of patients may explain the contradictory result. Patients with nulliparity, previous uterine surgery and a uterine size ⬎ 16 weeks, were excluded in Sesti’s study. Our study reported that MH had a shorter operative time, similar blood loss and early postoperative pain, without difference in complication rates, in spite of a significant larger uterine size in MH. Whereas, hospital stay was statistically significantly longer in MH, it may not have clinical significance. Although surgical outcomes are usually used, as primary endpoints in most studies, patient satisfaction after treatment is one of the most important parameters. There was no significant difference in terms of patient satisfaction levels and satisfaction VAS scores between the LH and MH in this study. The definition of minilaparotomy depends on the length of surgical incision, which is variably defined as ranging between 4 and 10 cm. The incision length of ⬍ 7 cm was used in this study. A few studies have reported MH technique with a smaller transverse incision of ⬍ 6 cm (Hoffman and Lynch 1998; Sharma et al. 2004; Alcalde et al. 2007; Royo et al. 2009). Special instruments, such as a uterine manipulator and a unique self-retaining elastic
abdominal retractor were essential. Furthermore, some studies have performed MH with different incisions. A cruciate incision (Kustner’s incision) has been used and is defined as a transverse skin incision but vertical incision on the deeper layers (Pelosi and Pelosi 2004; Panici et al. 2005; Alcalde et al. 2007; Muzii et al. 2007). Also a wider transverse incision on the deeper layers than the skin incision to a width of 10–12 cm has been utilised, allowing even greater exposure (Fanfani et al. 2005). On the contrary, a simple technique was used in our study with conventional Pfannenstiel incision, which is more familiar to most gynaecologists. Only an elastic wound retractor was required in our study. This kind of retractor is thought to be atraumatic with equal distribution of retraction force to the abdominal walls. The elastic sheath of the retractor can prevent contamination to the abdominal incision and reduce the abdominal wall thickness in obese patients. Less postoperative pain and quicker recovery time may result. We agree with Glasser that the size of incision in MH may not be the most important factor. Instead, meticulous technique minimising tissue trauma is of greater significance (Glasser 2005). The strength in this study was that patients with a contraindication for laparoscopy, such as previous pelvic surgery or pelvic adhesion were not excluded in our study. There was no difference in these parameters between both groups. Our study also compared MH and different types of laparoscopic hysterectomy (TLH). Other studies focused mainly on the difference between MH and LAVH. Furthermore, all procedures, either LH or MH, were performed together by these two authors. This may reduce the variation in surgical skills between the two approaches. Different teams of surgeons with different skill levels and experience were used in the other studies. This might result in different surgical outcomes. However, this may not be applicable to the wider gynaecological community. The limitation in this study was its retrospective nature. This may result in a selective bias. The patients with nulliparity and larger uterine size tended to be treated by the minilaparotomy. Although the MH had more difficult conditions, our findings still showed that MH was comparable with the laparoscopic approach regarding blood loss, intraoperative and postoperative complications, recovery time and patient satisfaction. However, MH had an
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Minilaparotomy vs laparoscopic hysterectomy 69 advantage over LH in terms of a shorter operative time. It might be an alternative technique for patients who may have a relative contraindication to LH. The other advantages of minilaparotomy approach were absence of CO2 pneumoperitoneum, good cosmetic result, short learning curve and low expense (Alcalde et al. 2007; Royo et al. 2009). The cost of the Alexis® retractor is approximately equal to only one disposable trocar at our institute. However, a randomised controlled trial to compare between MH and TLH would be necessary to adequately compare the perioperative outcomes, QOL and cost-effectiveness, especially in low resource settings. In conclusion, minilaparotomy hysterectomy is an alternative minimally invasive surgical technique. It is feasible in most patients with benign gynaecological diseases, especially in those with relative contraindications for vaginal or laparoscopic approaches. The procedure offers favourable outcomes in terms of operative time, early postoperative pain, hospital stay, recovery time and patient satisfaction.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
References Alcalde JL, Guiloff E, Ricci P, Solà V, Pardo J. 2007. Minilaparotomy hysterectomy assisted by self-retaining elastic abdominal retractor. Journal of Minimally Invasive Gynecology 14:108–112. Donnez O, Jadoul P, Squifflet J, Donnez J. 2009. A series of 3190 laparoscopic hysterectomies for benign disease from 1990 to 2006: evaluation of complications compared with vaginal and abdominal procedures. British Journal of Obstetrics and Gynaecology 116:492–500. Falcone T, Walters MD. 2008. Hysterectomy for benign disease. Obstetrics and Gynecology 111:753–767. Fanfani F, Fagotti A, Longo R, Marana E, Mancuso S, Scambia G. 2005. Minilaparotomy in the management of benign gynecologic disease.
European Journal of Obstetrics, Gynecology, and Reproductive Biology 119:232–236. Glasser MH. 2005. Minilaparotomy: A minimally invasive alternative for major gynecologic abdominal surgery. Permanente Journal 9:41–45. Hoffman MS, Lynch CM. Minilaparotomy hysterectomy. 1998. American Journal of Obstetrics and Gynecology 179:316–320. Kulier R, Boulvain M, Walker D, Candolle G, Campana A. 2004. Minilaparotomy and endoscopic techniques for tubal sterilisation. Cochrane Database of Systematic Reviews (3):CD001328. Kulkarni MM, Rogers RG. 2010. Vaginal hysterectomy for benign disease without prolapse. Clinical Obstetrics and Gynecology 53:5–16. Muzii L, Basile S, Zupi E, Marconi D, Zullo MA, Manci N et al. 2007. Laparoscopic-assisted vaginal hysterectomy versus minilaparotomy hysterectomy: a prospective, randomized, multicenter study. Journal of Minimally Invasive Gynecology 14:610–615. Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R et al. 2009. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database of Systematic Reviews (3):CD003677. Panici PB, Zullo MA, Angioli R, Muzii L. 2005. Minilaparotomy hysterectomy: a valid option for the treatment of benign uterine pathologies. European Journal of Obstetrics, Gynecology, and Reproductive Biology 119:228–231. Pelosi MA 2nd, Pelosi MA 3rd. 2004. Pelosi minilaparotomy hysterectomy: a non-endoscopic minimally invasive alternative to laparoscopy and laparotomy. Surgical Technology International 113:157–167. Purkayastha S, Tilney HS, Georgiou P, Athanasiou T, Tekkis PP, Darzi AW. 2007. Laparoscopic cholecystectomy versus mini-laparotomy cholecystectomy: a meta-analysis of randomised control trials. Surgical Endoscopy 21:1294–1300. Royo P, Alcàzar JL, Garcia-Manero M, Olartecoechea B, López-Garcia G. 2009. The value of minilaparotomy for total hysterectomy for benign uterine disease: a comparative study with conventional Pfannenstiel and laparoscopic approaches. International Archives of Medicine 2:11. Sesti F, Calonzi F, Ruggeri V, Pietropolli A, Piccione E. 2008. A comparison of vaginal, laparoscopic-assisted vaginal, and minilaparotomy hysterectomies for enlarged myomatous uteri. International Journal of Gynaecology and Obstetrics 103:227–231. Sharma JB, Wadhwa L, Malhotra M, Arora R. 2004. Mini laparotomy versus conventional laparotomy for abdominal hysterectomy: a comparative study. Indian Journal of Medical Sciences 58:196–202. Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. 2007. Hysterectomy rates in the United States, 2003. Obstetrics and Gynecology 110:1091–1095.
GYNAECOLOGY
Minilaparotomy vs laparoscopic hysterectomy for benign gynaecological diseases N. Sirisabya & T. Manchana
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Department of Obstetrics and Gynecology, Gynecologic Oncology Division, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Hysterectomy is the most frequent gynaecological procedure carried out with either conventional (abdominal) or minimally invasive surgery (MIS). Despite the advantage of MIS compared with the conventional procedure, it requires extensive training and a long learning curve. Minilaparotomy hysterectomy is an alternative approach that needs no sophisticated and expensive equipment or training. The objective of this study was to compare the perioperative outcomes between minilaparotomy hysterectomy (MH) and laparoscopic hysterectomy (LH) in patients with benign gynaecological diseases. A significantly shorter operative time was obtained in MH. There was no significant difference in blood loss and perioperative complications. However, a higher intraoperative complication (two bladder injuries and one major blood loss) were observed in the LH. Early postoperative VAS pain scores and recovery time were insignificantly different between both groups. Overall patient satisfaction levels and satisfaction scores were found to be similar in both groups, without significant difference. Keywords: Gynaecological disease, hysterectomy, laparoscopy, minilaparotomy, minimally invasive surgery
Introduction Hysterectomy is the most frequent gynaecological procedure, usually for benign gynaecological conditions, such as leiomyoma (Wu et al. 2003; Falcone and Walters 2008). There are three approaches: abdominal, vaginal and laparoscopic hysterectomy. Abdominal hysterectomy is a conventional approach, whereas the two latter techniques are considered as minimally invasive surgery (MIS), with less blood loss, shorter hospital stays, less febrile morbidity or infection and a quicker return to normal activities. Patients’ outcomes are similar between laparoscopic and vaginal hysterectomy, although shorter operative time is reported in vaginal hysterectomy (Nieboer et al. 2009). However, large uterine size, pelvic adhesion from previous abdominal surgery or endometriosis, absence of uterine descent and limited vaginal exposure may constraint its usability. Furthermore, these two MIS techniques require intensive training and a long learning curve. Hence, abdominal hysterectomy remains the most common technique performed by gynaecologists in the USA (Wu et al. 2003). Minilaparotomy hysterectomy is an alternative approach. Surgical technique is similar to the conventional laparotomy, without the need of sophisticated and expensive equipment and lengthy
training. This approach satisfies the criteria of MIS because of a small surgical incision with less postoperative pain. It also has comparable outcomes with respect to laparoscopy in many surgical procedures such as cholecystectomy and tubal sterilisation (Kulier et al. 2004; Purkayastha et al. 2007). Minilaparotomy was also reported to be applicable for hysterectomy, myomectomy, salpingo-oophorectomy, and cystectomy in benign gynaecological diseases (Fanfani et al. 2005). The aim of this study was to compare the perioperative outcomes, including time to return to normal activity, and patient satisfaction between minilaparotomy and laparoscopic hysterectomy.
Materials and methods Patients and operation procedures This retrospective study was conducted in 100 patients undergoing hysterectomy for benign gynaecological conditions, such as leiomyoma, adenomyosis, benign ovarian cyst, cervical intraepithelial neoplasia (CIN) and dysfunctional uterine bleeding (DUB). These patients were operated at the King Chulalongkorn Memorial Hospital between July 2009 and April 2012. All surgical procedures were performed by the two authors. Prophylactic antibiotic (cefazolin 1 g or ceftriaxone 1 g) was given 30 min before operation. If the patients had a history of allergy to cephalosporin, clindamycin 900 mg was administered. The patients were categorised into two groups; laparoscopic hysterectomy (LH) and minilaparotomy hysterectomy (MH). The patients in the LH were performed under general anaesthesia (GA) in the steep lithotomy position. A Foley catheter and uterine manipulator was inserted. The 5 mm laparoscope was introduced under direct visualisation by bladeless trocar (ENDOPATH® XCELTM, Ethicon Endo-Surgery, Cincinnati, OH) at the umbilicus followed by CO2 pneumoperitoneum. The other two 5 mm trocars were inserted at the right and left lower quadrants. The last 5 mm trocar was inserted at the left side of abdomen between the umbilical and left lower quadrant port (Figure 1). After thorough abdominal exploration, the round ligaments were resected and retroperitoneal spaces were opened to identify the ureters. Then, the infundibulopelvic ligaments or the uteroovarian ligaments were excised, depending on whether oophorectomy was planned. All procedures were performed using a Harmonic scalpel (Ethicon Endo-Surgery). The anterior and posterior leafs of the broad ligament were excised and bladder flap was developed. The uterine vessels were sealed and culdotomy was done
Correspondence: T. Manchana, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand. E-mail: [email protected]
66
N. Sirisabya & T. Manchana anaesthesia. A Pfannenstiel incision with the length ⱕ 7 cm was done (Figure 2A). A wound retractor (Alexis®, Applied Medical, Rancho Santa Margarita, CA) was placed to widen the operative field (Figure 2B, C). The surgical steps were performed according to the standard technique. After the uterine vessels were ligated, uterine morcellation with a scalpel was done to reduce the uterine size and the uterus was elevated out of the surgical field (Figure 2D). If an ovarian cyst was larger than the incision, cyst content was aspirated without intraperitoneal contamination. The remaining steps were performed by standard technique. Vaginal cuff closure was done by continuous suture, with delay absorbable suture No.1.
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Data collection and statistical analysis Figure 1. Location of all port sites in laparoscopic hysterectomy group.
from anterior to posterior using a monopolar hook. The uterus was morcellated by a scalpel to reduce uterine size, if it could not be removed vaginally. The vaginal cuff was sutured transvaginally in continuous suture using delay absorbable suture No. 1. Haemostasis was re-evaluated through the laparoscope at the end of the procedure. The patients in the MH were placed in the supine position under spinal anaesthesia, with 0.5% heavy Marcaine, combined with morphine 0.2 mg. However, GA was administered in some patients if they requested or had contraindications for spinal
Intraoperative data included operative time, blood loss, intraoperative complications, uterine size according to gestational weeks, uterine weight, rates of conversion to laparotomy in the LH or conversion to a larger incision in the MH, and length of skin incision for the MH. Postoperative complications were defined as any unfavourable events within the first 30 days after surgery. This included febrile morbidity, which was defined as body temperature ⱖ 38°C in two consecutive measurements at least 6 h apart but excluded the first 24 h. Postoperative pain was evaluated every 6 h on the first and second postoperative day (POD) by visual analogue scale (VAS): 0–10 scores (0 ⫽ no pain; 10 ⫽ worst pain). The worst score in each day was used for analysis. Pain control in the first 24 h in the LH and MH who had GA was intravenous opioid (morphine or pethidine) every 4 h. Spinal anaesthesia
Figure 2. (A) Minilaparotomy hysterectomy with Pfannenstiel incision ⱕ 7 cm. (B) Alexis® (Applied Medical, Rancho Santa Margarita, CA). (C) Alexis® was placed to widen operative field. (D) Uterus was morcellated by scalpel to reduce uterine size.
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Minilaparotomy vs laparoscopic hysterectomy 67 with morphine and rescue doses of intravenous Tramadol 50 mg every 4–6 h were given as the pain control regimen within the first 24 h for the MH. If there were no contraindications, Celecoxib (Celebrex®) 400 mg or Etoricoxib (Arcoxia®) 120 mg were prescribed once daily starting on the second POD and continued for 7 days in both groups. Otherwise, acetaminophen or any nonsteroidal anti-inflammatory drugs (NSAID) were prescribed. The patients were discharged if they ambulated, tolerated soft diet and had no significant complications. The duration of hospital stay was recorded. The time to return to normal activity and patient satisfaction were recorded. Satisfaction was graded as follows: 0 ⫽ very unsatisfied; 1 ⫽ somewhat unsatisfied; 2 ⫽ neither satisfied nor unsatisfied; 3 ⫽ somewhat satisfied; 4 ⫽ very satisfied. Moreover, satisfaction was scored by VAS (0–10 scores). χ2-test or Fisher’s exact test was used to analyse categorical data. Student’s t-test and Mann–Whitney U test was used to compare parametric and non-parametric continuous data, respectively. A p value of ⬍ 0.05 was considered statistically significant.
Results The most common indication for hysterectomy was leiomyoma (62.5%). Other indications were as follows: adenomyosis (16.3%); ovarian tumour (12.5%); CIN3 (3.8%); DUB (1.3%) and others (2.5%). However, there was no difference of indications between both groups. The patients’ characteristics were similar, except for lower parity and larger size of uterus in the MH (Table I). Most patients in the MH were nulliparous. Median length of surgical incision in the MH was 6 cm (range 4–7). There was one patient in the LH (2.4%) that required conversion to abdominal hysterectomy, due to severe pelvic adhesion and major blood loss. This patient had adenomyosis with severe pelvic endometriosis. She also had one previous laparoscopic cystectomy for endometriotic cyst. However, minilaparotomy approach (6 cm of surgical incision) was performed successfully in this patient. In contrast, there was no patient in the MH group who was converted to conventional abdominal hysterectomy. Our study indicated a significantly shorter operative time in MH without a difference in term of blood loss and complications when compared with LH (Table II). Nonetheless, more intraoperative complications were found in LH (two bladder injuries; one major bleeding that required blood transfusion); it did not reach statistical significance however. There was no febrile morbidity, wound infection and wound separation or
vaginal cuff dehiscence in either group. Low early postoperative VAS pain scores were reported in both groups without significant difference. Pain was relieved by oral analgesic drugs in all patients. A significantly shorter hospital stay was reported in the LH group. Mean time to return to normal activity was up to 3 weeks in both groups, without significant difference. Importantly, there was no significant difference in the satisfaction levels and satisfaction scores between both groups, with almost all of the patients indicating satisfied or very satisfied (Table II).
Discussion There is a consensus that hysterectomy by MIS technique is superior to the conventional technique (Falcone and Walters 2008). A Cochrane review showed that vaginal hysterectomy is preferable to abdominal hysterectomy. If this is not feasible, then laparoscopic hysterectomy is the alternative choice (Nieboer et al. 2009). Vaginal hysterectomy has comparable outcomes with laparoscopic hysterectomy, except for a shorter operative time. However, previous caesarean delivery, nulliparity or no prior vaginal delivery, large uterus, lack of uterine descent and planned oophorectomy, are relative contraindications for vaginal hysterectomy (Kulkarni and Rogers 2010). Although, the benefits of vaginal hysterectomy are recognised, many gynaecologists are uncomfortable with this technique. Previous reports showed a decline in the number of vaginal hysterectomies, while the number of laparoscopic hysterectomies has increased (Donnez et al. 2009). Laparoscopic hysterectomy has several reported advantages compared with the conventional abdominal hysterectomy, including reduction in postoperative pain, less blood loss, shorter hospital stay and faster recovery. Nonetheless, its drawbacks are longer operative time, expensive equipment, required special training and a longer learning curve (Hoffman and Lynch 1998). Thus, the benefit of laparoscopic surgery was reported only by experienced surgeons. Moreover, patients with large uterine size, large ovarian cyst, pelvic adhesion, previous pelvic surgery and cardiopulmonary compromise contraindicating for pneumoperitoneum, eliminate their candidacy for laparoscopic surgery. In addition, tumour rupture or spillage of cyst content during laparoscopy is a major concern, especially in an unexpected diagnosis of ovarian cancer. Minilaparotomy may be an alternative MIS technique for hysterectomy, especially in specific conditions such as large uterine
Table I. Patients’ characteristics. Minilaparotomy hysterectomy (n ⫽ 59) n Age (years) (mean ⫾ SD) Parity (median, range) Nulliparous BMI (kg/m2) (mean ⫾ SD) Menopause Previous pelvic surgery Pelvic adhesion Uterine size (gestational weeks) (median, range) Uterine weight (g) (median, range) Size of ovarian tumour (cm) (median, range) BMI, Body mass index.
46.0 ⫾ 7.5 0 (0–4) 35 23.9 ⫾ 4.3 5 9 10 14 (6–24) 309.0 (35–1655.5) 6 (4–12), n ⫽ 8
(%)
59.3 8.5 15.3 16.9
Laparoscopic hysterectomy (n ⫽ 41) n 47.8 ⫾ 7.7 2 (0–4) 15 23.8 ⫾ 3.8 8 13 7 8 (5–14) 164.3 (55.6–522.7) 5 (2–10), n ⫽ 9
(%)
36.6 19.5 31.7 17.1
p value 0.24 0.01 0.01 0.93 0.09 0.08 0.60 ⬍ 0.001 ⬍ 0.001 0.54
68
N. Sirisabya & T. Manchana Table II. Perioperative outcomes and patient satisfaction. Minilaparotomy hysterectomy (n ⫽ 59)
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n Operative time (min) (mean ⫾ SD) Blood loss (ml) (mean ⫾ SD) Conversion rate Postoperative VAS pain scores on the first POD (median, range) Postoperative VAS pain scores on the second POD (median, range) Intraoperative complication Hospital stay (days) (mean ⫾ SD) Time to return to normal activity (days) (mean ⫾ SD) VAS satisfaction scores (mean ⫾ SD) Satisfaction level Very unsatisfied Somewhat unsatisfied Neither satisfied nor unsatisfied Somewhat satisfied Very satisfied
81.9 ⫾ 19.6 250.8 ⫾ 185.3 0 2 (0–10)
(%)
0
1 (0–7) 0 2.9 ⫾ 0.6 21.7 ⫾ 9.3
n 107.4 ⫾ 32.3 215.8 ⫾ 165.2 1 2 (0–7)
(%)
2.4
1 (0–3) 0
9.3 ⫾ 1.0 0 0 1 25 33
Laparoscopic hysterectomy (n ⫽ 41)
3 2.5 ⫾ 1.1 20.1 ⫾ 9.4
0 0 1 15 25
⬍ 0.001 0.45 0.41 0.80 0.06
7.3
9.5 ⫾ 0.8 0 0 1.7 42.4 55.9
p value
0.07 0.02 0.40 0.25 0.83
0 0 2.4 36.6 61.0
VAS, visual analogue scale; POD, postoperative day.
size, pelvic adhesion, previous pelvic surgery and patients with morbid obesity or cardiopulmonary compromise (Hoffman and Lynch 1998; Pelosi and Pelosi 2004; Sharma et al. 2004; Fanfani et al. 2005; Panici et al. 2005; Alcalde et al. 2007). A previous nonrandomised comparative study reported that MH had shorter operative time, less blood loss, shorter hospital stay, faster recovery and fewer complications than the conventional abdominal hysterectomy (Sharma et al. 2004). However, the use of a vertical incision instead of a transverse incision and larger uterine size in the abdominal hysterectomy group, may confound the study’s conclusion. Various comparative studies between laparoscopicassisted vaginal hysterectomy (LAVH) and MH were reported (Muzii et al. 2007; Sesti et al. 2008). Muzii et al. (2007) reported that LAVH had significantly longer operative time, lower early postoperative pain scores, and lower complication rates than MH. In contrast, Sesti et al. (2008) reported no significant difference regarding operative time and complications between MH and LAVH. However, MH had significantly greater blood loss during operation and longer hospital stay. The heterogeneity of patients may explain the contradictory result. Patients with nulliparity, previous uterine surgery and a uterine size ⬎ 16 weeks, were excluded in Sesti’s study. Our study reported that MH had a shorter operative time, similar blood loss and early postoperative pain, without difference in complication rates, in spite of a significant larger uterine size in MH. Whereas, hospital stay was statistically significantly longer in MH, it may not have clinical significance. Although surgical outcomes are usually used, as primary endpoints in most studies, patient satisfaction after treatment is one of the most important parameters. There was no significant difference in terms of patient satisfaction levels and satisfaction VAS scores between the LH and MH in this study. The definition of minilaparotomy depends on the length of surgical incision, which is variably defined as ranging between 4 and 10 cm. The incision length of ⬍ 7 cm was used in this study. A few studies have reported MH technique with a smaller transverse incision of ⬍ 6 cm (Hoffman and Lynch 1998; Sharma et al. 2004; Alcalde et al. 2007; Royo et al. 2009). Special instruments, such as a uterine manipulator and a unique self-retaining elastic
abdominal retractor were essential. Furthermore, some studies have performed MH with different incisions. A cruciate incision (Kustner’s incision) has been used and is defined as a transverse skin incision but vertical incision on the deeper layers (Pelosi and Pelosi 2004; Panici et al. 2005; Alcalde et al. 2007; Muzii et al. 2007). Also a wider transverse incision on the deeper layers than the skin incision to a width of 10–12 cm has been utilised, allowing even greater exposure (Fanfani et al. 2005). On the contrary, a simple technique was used in our study with conventional Pfannenstiel incision, which is more familiar to most gynaecologists. Only an elastic wound retractor was required in our study. This kind of retractor is thought to be atraumatic with equal distribution of retraction force to the abdominal walls. The elastic sheath of the retractor can prevent contamination to the abdominal incision and reduce the abdominal wall thickness in obese patients. Less postoperative pain and quicker recovery time may result. We agree with Glasser that the size of incision in MH may not be the most important factor. Instead, meticulous technique minimising tissue trauma is of greater significance (Glasser 2005). The strength in this study was that patients with a contraindication for laparoscopy, such as previous pelvic surgery or pelvic adhesion were not excluded in our study. There was no difference in these parameters between both groups. Our study also compared MH and different types of laparoscopic hysterectomy (TLH). Other studies focused mainly on the difference between MH and LAVH. Furthermore, all procedures, either LH or MH, were performed together by these two authors. This may reduce the variation in surgical skills between the two approaches. Different teams of surgeons with different skill levels and experience were used in the other studies. This might result in different surgical outcomes. However, this may not be applicable to the wider gynaecological community. The limitation in this study was its retrospective nature. This may result in a selective bias. The patients with nulliparity and larger uterine size tended to be treated by the minilaparotomy. Although the MH had more difficult conditions, our findings still showed that MH was comparable with the laparoscopic approach regarding blood loss, intraoperative and postoperative complications, recovery time and patient satisfaction. However, MH had an
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Minilaparotomy vs laparoscopic hysterectomy 69 advantage over LH in terms of a shorter operative time. It might be an alternative technique for patients who may have a relative contraindication to LH. The other advantages of minilaparotomy approach were absence of CO2 pneumoperitoneum, good cosmetic result, short learning curve and low expense (Alcalde et al. 2007; Royo et al. 2009). The cost of the Alexis® retractor is approximately equal to only one disposable trocar at our institute. However, a randomised controlled trial to compare between MH and TLH would be necessary to adequately compare the perioperative outcomes, QOL and cost-effectiveness, especially in low resource settings. In conclusion, minilaparotomy hysterectomy is an alternative minimally invasive surgical technique. It is feasible in most patients with benign gynaecological diseases, especially in those with relative contraindications for vaginal or laparoscopic approaches. The procedure offers favourable outcomes in terms of operative time, early postoperative pain, hospital stay, recovery time and patient satisfaction.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
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