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Vaginal Hysterectomy for Enlarged Uteri, With or Without Laparoscopic Assistance: Randomized Study

From the Service de Gynécologie, Hôpital Hôtel-Dieu de Paris and Service de Gynécoloie Hôpital Boucicaut, Paris, France.

Address reprint requests to: Emile Daraï, MD, PhD Service de Gynécologie Hôpital Hôtel-Dieu de Paris 2 rue d’Arcole 75004 Paris France E-mail: emile.darai{at}htd.ap-hop-paris.fr

	Abstract

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Objective: To compare short-term results of vaginal hysterectomy (VH) with those of laparoscopically assisted vaginal hysterectomy (LAVH) in women with enlarged uteri.

Methods: Eighty women referred for abdominal hysterectomies for benign disease were assigned randomly to vaginal hysterectomy or LAVH. Inclusion criteria were uterine size larger than 280 g and one or more of the following traditional contraindications of vaginal hysterectomy: previous pelvic surgery, history of pelvic inflammatory disease, moderate or severe endometriosis, concomitant adnexal masses, indication for adnexectomy, and nulliparity without uterine descent.

Results: There were no differences in patients’ mean age, parity, rate of postmenopausal state, previous pelvic surgery, preoperative hemoglobin levels, and mean uterine weight. Indications for surgery were similar between groups. No difference was found in the mean ± standard deviation (SD) uterine weight (range) between vaginal hysterectomy and LAVH groups (424 ± 211 g [280–930 g] and 513 ± 360 g [290–1560 g]), respectively. Except for one bladder injury in the laparoscopic group (injury treated laparoscopically), there were no other major complications. Complication rates in vaginal and laparoscopic groups were 15% and 37.5%, respectively (P < .05). Mean operating time was shorter in the vaginal than the laparoscopic group (108 ± 35 minutes and 156 ± 50 minutes, respectively [P < .001]). There was no difference in first day hemoglobin level drops or hospital stays between groups.

Conclusion: Vaginal hysterectomy can be successful even in women with enlarged uteri and other conditions considered by some to contraindicate the operation. Laparoscopically assisted vaginal hysterectomy offered no advantages over the standard vaginal hysterectomy.

The rationale for laparoscopically assisted vaginal hysterectomy (LAVH) is to replace abdominal hysterectomy with the laparoscopic vaginal procedure to reduce trauma and morbidity.¹ Laparoscopically assisted vaginal hysterectomy is currently accepted as a safe and efficient way to manage benign uterine disease and as an acceptable alternative to standard abdominal hysterectomy.^2–7 The advantages include reduced postoperative pain and discomfort, with less need for analgesia, and shorter hospitalization and rapid recovery.^2–5 Much effort was put in randomized controlled trials that compared laparoscopic and abdominal hysterectomies,^2–6 although many subjects were candidates for vaginal surgery.⁸ The vaginal hysterectomy route is preferable when it can be done, but guidelines for choosing the proper route are still debated. Inappropriateness of many of the traditional relative contraindications to vaginal hysterectomy, although reported, were not challenged enough. Therefore, although LAVH has advantages over abdominal hysterectomy, the main question remains, "why not do hysterectomies vaginally?"

The aims of our study were to evaluate feasibility and complication rate of vaginal hysterectomy in women with enlarged uteri and other contraindications of vaginal hysterectomy, and to compare short-term results for vaginal hysterectomy and LAVH.

	Materials and Methods

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From January to December 1999, women admitted with indications for abdominal hysterectomy for benign disease were evaluated at the Service de Gynécologie, Hôpital Hôtel-Dieu de Paris and in the Service de Gynécologie, Hôpital Boucicaut, Paris. Inclusion criteria were traditional contraindications for vaginal hysterectomy, including uterine size larger than 280 g and one or more of the following; previous pelvic surgery, history of pelvic inflammatory disease, moderate or severe endometriosis, concomitant adnexal masses, or indication for adnexectomy. Exclusion criteria included anesthetic contraindications for laparoscopic surgery and suspicious adnexal mass based on ultrasonographic examination, ovarian blood flow, and tumor markers. We also excluded women with vaginas narrower than two fingers wide and immobile uteri with no descent and no lateral mobilization. No upper limit of uterine size was set.

During outpatient consultation, women were informed of the study and asked to participate. Eighty women were assigned randomly to vaginal hysterectomy or LAVH (40 per group) using a predetermined computer-generated randomization code. Each subject gave approval after receiving a detailed explanation of risks associated with anesthesia and complications of abdominal and vaginal hysterectomy. Women had preoperative clinical evaluation of uterine size and mobility, pelvic ultrasonography, and when indicated diagnostic hysteroscopy and endometrial sampling. No woman was treated with GnRH agonist before the operation. Hemoglobin and hematocrit were measured, and autologous blood transfusion was permitted if hemoglobin level was at least 11 g/dL.

Each subject received prophylactic antibiotic treatment (cefazoline 2 g intravenously [IV]) at the beginning of the operation and prophylactic anticoagulant therapy with low molecular weight heparin the evening before the operation. All operations were done under endotracheal general anesthesia. Surgeons experienced in laparoscopic and vaginal surgery did all procedures.

Laparoscopic procedures were done with women in the modified dorsal-lithotomy position. Women were monitored continuously for blood pressure (BP), electrocardiogram, transcutaneous oxygen saturation, and end-tidal carbon dioxide (CO₂) pressure. A Veress needle was inserted through the umbilicus or supraumbilicus, depending on uterine size, and the abdomen was insufflated with CO₂. After induction of pneumoperitoneum and insertion of the videolaparoscope, three suprapubic trocars were introduced as ancillary instruments (Karl Storz, Tuttlingen, Germany). The laparoscopic procedure included coagulation and sectioning of the round ligament, uteroovarian ligaments with fallopian tubes when ovaries were conserved, and the infundibulopelvic ligaments when ovaries were removed; the opening of the bladder flap and bladder dissection, uterosacral ligaments, base of cardinal ligaments, and uterine vessels.

When ovaries were conserved, bipolar forceps and scissors were used to resect the round ligament and utero-ovarian ligaments with the fallopian tubes. For adnexectomy, bipolar forceps and scissors were used to resect the round and the infundibulopelvic ligaments, mesosalpinx, and mesovarium. Laparoscopic procedures included opening the bladder flap and bladder dissection, and coagulating and transecting the utero-sacral ligaments, base of cardinal ligaments, and uterine vessels. Laparoscopic hemostasis was achieved using exclusively bipolar electrocoagulation. Vaginal phases included only circular incision of the vagina and, when necessary, wedge morcellation, coring, or bivalving. Peritoneal closure and closure of the vaginal vault concluded the vaginal phase, at which time the pelvis and the abdomen were reevaluated through the laparoscope to be sure of hemostasis and for pelvic lavage. Because the uterosacral ligaments and uterine vessels were secured during the laparoscopic phase, the procedure was considered LAVH type IV.⁹

Vaginal hysterectomy was done according to modified Heaney technique.¹⁰ Wedge morcellation, coring, or bivalving was done when necessary. At the end of each operation, removed uteri were weighed before being placed in formalin for histologic evaluation.

The duration of LAVH was calculated from insertion of the Veress needle to placement of the last suture of the skin closure, including the vaginal phase and the time needed for adjusting the position of the patient to the vaginal phase. The duration of vaginal hysterectomy was calculated from the circular incision of the vagina to placement of the last suture of the vaginal vault closure.

Postoperative fever was considered to be body temperature at least 38C in two consecutive measurements at least 6 hours apart, excluding the first 24 hours. The incidence of intraoperative and postoperative complications, febrile morbidity, analgesia requirements, and postoperative hospital stay were recorded in all cases. Women were reviewed 6–8 weeks after surgery. Data on the patient characteristics and immediate and short-term postoperative outcome were available from the patient hospital and outpatient medical records.

Statistical analysis was done with Student t test and the Wilcoxon rank-sum test for parametric and nonnormally distributed continuous variables, respectively, and ² test or Fisher exact test for categorical variables, as appropriate. P < .05 was considered statistically significant. The power calculation used to estimate study size assumed that the incidence of complications in women who had laparoscopic hysterectomies was 10% and there was an increase of complication rate to 40%, with an (type I error) of 0.05 and a ß (type II error) of 0.2. We planned to recruit at least 35 women to each surgery arm.

	Results

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There were no differences between groups in age, parity, weight, premenopausal state, or previous pelvic surgery (Table 1). There was no difference in indications for surgery between groups. The most common indications for surgery were myoma and abnormal uterine bleeding; however, most women presented with more than one indication. No difference was found in the mean ± tandard deviation (SD) uterine weight (range) between vaginal hysterectomy and LAVH groups (424 ± 211 g [280–930] and 513 ± 360 g [290–1560], respectively, and vaginal morcellation of uteri was done in all women in both groups. The most common pathologic diagnoses in both groups were myoma and adenomyosis, with no significant differences between groups.

There was no difference in the mean ± SD hemoglobin decrease the first day between groups (2.0 ± 1.2 compared with 2.1 ± 1.4 in the vaginal hysterectomy and LAVH groups, respectively). The mean ± SD operating time (range) was 108 ± 35 minutes (60–270 minutes) and 160 ± 50 minutes (60–180 minutes) in the vaginal hysterectomy and the LAVH groups, respectively (P < .001). The mean ± SD (range) hospital stay was 5.3 ± 2.1 days (3–11 days) compared with 5.7 ± 3.0 days (3–7 days) in the vaginal hysterectomy and LAVH groups, respectively.

	Discussion

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The main conclusion from our study is that vaginal hysterectomy can be successful in most women with enlarged uteri who have relative contraindications of vaginal surgery. Although our sample was small, women randomly assigned to vaginal hysterectomy completed the operation vaginally. Our results are consistent with reports by Kovac et al⁸ and Richardson et al,⁹ who found that among women with large uteri who had vaginal hysterectomies, this procedure could be successful using the vaginal route in 42 of 46 (91.3%) and 21 of 23 (91.3%) women, respectively. Those observations imply that too many hysterectomies are being done abdominally. There are unjustified relative contraindications for vaginal hysterectomies, so some of those hysterectomies are now referred to LAVH.

During the past decade, efforts were made to show the advantages of laparoscopic over abdominal hysterectomies. Randomized trials showed the advantages of laparoscopy over laparotomy, including reduced postoperative pain and discomfort, with less need for analgesia, shorter hospitalization, and rapid recovery,^1–4,6,9 with substantial financial benefits to society.¹¹ Much less effort was made to reexamine relative contraindications for vaginal hysterectomy. In the randomized trial of Summitt et al,¹² they found that vaginal hysterectomy was similar to LAVH except for significantly lower cost using the vaginal route. However, their patients were candidates for vaginal surgery, which raised an ethical question on the adequacy of laparoscopic surgery in women who are ideal candidates for standard vaginal hysterectomy. Richardson et al⁹ concluded that laparoscopic hysterectomy is a waste of time (and money) because vaginal hysterectomy is a shorter procedure. Our results support those findings.

We and others^9,14 believe that the main step in hysterectomy is securing the uterine vessels. There is no point comparing LAVH type I-II, in which all main steps are done vaginally, with vaginal hysterectomy. Reich¹⁴ declared in his LAVH review that the sine qua non for laparoscopic hysterectomy is laparoscopic ligation of the uterine vessels. That study, in contrast with others,⁹ included only LAVH type IV.

It should be stressed that laparoscopy is still associated with complications related to general anesthesia and abdominal entry, including life-threatening major vascular injuries.^15,16 Reports have shown that even experienced laparoscopists have complication rates of 5.8–11.5%, with major complication rates of 2.2–2.7% after laparoscopic hysterectomies for benign uterine disease.^17,18 In a meta-analysis by Garry and Phillips,¹⁹ they reported a total complication rate of 15.6%, which was comparable with the Finnish national register of laparoscopic hysterectomies.¹⁶ In that study, they found a lower total complication rate in the vaginal hysterectomy group compared with the LAVH group. The only major complication, one bladder injury, was in the laparoscopic group. Unger²⁰ evaluated the association between complication rate and uterine size in women who had vaginal hysterectomy. He found a similar major complication rate after vaginal hysterectomy in women with enlarged or normal uteri.

We are aware of the limitations of the sample of our study; however, as a center that specializes in vaginal surgery, nearly 80% of our hysterectomies are done vaginally. Therefore, recruitment to laparoscopy is extremely difficult. A randomized trial of LAVH versus vaginal hysterectomy large enough to detect a 50% increase in injuries based on a 4% incidence of major complications for a one-tailed test at an (type I error) of 0.05 and ß (type II error) of 0.2 would require 1460 women in each arm. It is not reasonable to expect that one could recruit such a number if the informed consent included data that vaginal hysterectomy is preferable when possible.

There is no doubt that the vaginal route is preferable if possible. The main debate is on guidelines to decide the route.² The ACOG guidelines for hysterectomy route state that the choice "depends on the patient’s anatomy and the surgeon’s experience" and it is usually done in women with mobile uteri no larger than one at 12 weeks’ gestation (280 g).²² Indications for abdominal hysterectomy are usually determined from the standard surgical text.²³ Those indications include uterine size larger than 280 g, previous pelvic surgery, and history of pelvic inflammatory disease, endometriosis, concomitant adnexal masses, and indication for adnexectomy. However, Kovac²¹ was able to do vaginal hysterectomies in 97% of women who had those presumptive risk factors that are believed to mandate abdominal hysterectomy.

The mean weight of uteri removed in the present study was high above the limit of 280 g (12 weeks’ gestation) that was recommended as the limit for vaginal hysterectomy.^21,22 In more than 30% of cases the uterine weight was at least 500 g with no special difficulties. Therefore, as Magos et al²⁴ concluded, uterine size by itself should no longer be considered a contraindication to vaginal hysterectomy. As reported,^9,20 previous pelvic surgery, mild endometriosis, history of pelvic inflammatory disease, or uterine fibroids should no longer be regarded as contraindications for vaginal surgery.

One concern in the literature on vaginal hysterectomy is prophylactic adnexectomy, which is much less frequent at the time of vaginal hysterectomy because of technical difficulties in securely ligating the ovarian vessels. Wilcox et al²⁵ analyzed data from the National Hospital Discharge Survey on hysterectomy in the United States and found that although prophylactic oophorectomy was done in 85% of the women over 45 years old who had abdominal hysterectomies, the same procedure was done in only 18% of women who had vaginal hysterectomy. However, previous reports found that prophylactic oophorectomy can be successful in 94% of women when indicated.²⁶ In our study, whenever oophorectomy was indicated, it was successful (52.5%) with no difference between routes.

From our experience, and other reports,^20,23,27,28 contraindications to vaginal hysterectomy should be reserved for women with indications for hysterectomy and very narrow vaginas with no uterine descent or suspected ovarian masses. In cases of suspected ovarian masses, diagnostic laparoscopy can help determine hysterectomy route. Therefore, laparoscopic assistance should not supplant inadequate surgical abilities and selection of route of hysterectomy should be determined by clinical indications.

	Footnotes

 
PII S0029-7844(01)01194-2

Received October 5, 2000. Received in revised form December 12, 2000. Accepted January 18, 2001.

	References

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