BMJ  2004;328:129 (17 January), doi:10.1136/bmj.37984.623889.F6 (published 7 January 2004)

Paper

The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy

¹ University of Western Australia, Department of Obstetrics and Gynaecology, King Edward Memorial Hospital, Subiaco, Perth, WA 6008, Australia, ² Northern and Yorkshire Clinical Trials and Research Unit, University of Leeds, Leeds LS2 9NG, ³ James Cook University Hospital, Middlesbrough TS4 3BW, ⁴ Royal Women's Hospital, University of New South Wales, Randwick NSW 2031, Australia, ⁵ St James's University Hospital, Leeds LS9 7TF, ⁶ Department Public Health and Epidemiology, University of Birmingham, Birmingham B15 2UP, ⁷ Newcastle under Lyme Primary Care Trust, Newcastle-under-Lyme, Staffordshire ST5 7NJ

Abstract

Objective To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial.

Design Two parallel, multicentre, randomised trials.

Setting 28 UK centres and two South African centres.

Participants 1380 women were recruited; 1346 had surgery; 937 were followed up at one year.

Primary outcome Rate of major complications.

Results In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, -5.2% to 5.8%), and the number needed to treat to harm was 333. We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered.

Conclusions Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time.

Introduction

Ten previous randomised trials have compared outcomes for abdominal hysterectomy with laparoscopic hysterectomy.^1-10 Most of these were from single centres of endoscopic surgical excellence and had small study populations. Each trial showed that laparoscopic hysterectomy was associated with reduced hospital stay and, in most studies, a shorter time to convalescence and notably less pain than abdominal hysterectomy.

Only four previously published randomised trials have compared the outcomes of vaginal hysterectomy and laparoscopic hysterectomy.^11-14 The only difference shown in these studies was that laparoscopic hysterectomy took longer to perform.

We know of no previous trials that were powered to investigate the safety of the various procedures. We have therefore undertaken a concurrent pair of randomised controlled trials to eVALuate the relative roles of Vaginal, Abdominal, and Laparoscopic hysterectomy in routine gynaecological practice.

Methods

Design
One trial compared laparoscopic hysterectomy with abdominal hysterectomy (abdominal trial), and the second compared laparoscopic hysterectomy with vaginal hysterectomy (vaginal trial).

Participants
Patients who needed a hysterectomy for non-malignant conditions were eligible; excluded were patients who had a second or third degree uterine prolapse, a uterine mass greater than the size of a 12 week pregnancy, a medical illness precluding laparoscopic surgery, or a requirement for bladder or other pelvic support surgery, and patients who refused consent.

Major complications Major haemorrhage (requiring transfusion) Haematoma requiring transfusion or surgical drainage Bowel injury Ureteric injury Bladder injury Pulmonary embolus Major anaesthesia problems Unintended laparotomy Wound dehiscence

Gynaecologists were responsible for recruitment and on clinical grounds entered patients for randomisation into either the abdominal or the vaginal trial. Follow up of patients took place in a clinic at six weeks and then by postal questionnaire, at four months and one year after their operation.

Interventions
Surgical procedures were as currently practised, with four approaches to laparoscopic hysterectomy: laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic supracervical hysterectomy, and total laparoscopic hysterectomy. All conversions were documented. Each surgeon's practice standardised antibiotics, analgesia, anticoagulants, anaesthetic care, and advice concerning resumption of normal activities over the three types of operation.

Outcome measures
The primary end point of the trials was the occurrence of at least one major complication (box). Secondary end points were minor complications (haemorrhage not requiring transfusion; infection; haematoma; deep vein thrombosis; cervical stump problems; minor anaesthesia problems), blood loss, pain measured by a visual analogue scale and analgesia requirements, and questionnaire assessments of sexual activity,¹⁵ body image,¹⁶ and health status (SF-12).¹⁷

Sample size and analysis
The sample size for the abdominal trial was based on detecting a relative reduction in complication rates of 50% from 9%¹⁸; 487 patients in each arm were 80% power and 5% significance (two sided). The complication rate in the vaginal trial was expected to be 4% for vaginal hysterectomy.¹⁹ To detect a 50% reduction in this rate, 1141 patients were required per treatment arm. We did not expect to recruit this number but wanted to collect the randomised data as this would represent the largest such trial of vaginal hysterectomy that we are aware of.

The primary analysis was by intention to treat.

Results

Forty three gynaecologists from 28 UK and two South African centres recruited 876 patients into the abdominal trial and 504 into the vaginal trial between November 1996 and September 2000.

Demography
Baseline characteristics were well matched in each of the allocated trials (table 1).

View this table: [in this window] [in a new window]   Table 1 Baseline characteristics of participants in the two trials. Values are numbers (percentages) of participants unless otherwise indicated

 

The main indications for hysterectomy were dysfunctional uterine bleeding (874/1380 cases, 63%), fibroids (235 cases, 17%), pelvic pain (151 cases, 11%), endometriosis (126 cases, 9%), and failed ablation (104 cases, 8%).

Numbers analysed
The figure shows the flow of patients through the trials.

View larger version (62K): [in this window] [in a new window]   Flow of participants through the trials. Follow up forms not received within the appropriate time frames were not included in the analysis. The time frames were 14 days at six weeks and 28 days at four months and one year

 

Primary outcome
In the abdominal trial significantly more patients undergoing laparoscopic hysterectomy than patients undergoing abdominal hysterectomy had at least one major complication (mean difference 4.9%, 95% confidence interval 0.9% to 9.1%; odds ratio 1.91, 1.11 to 3.28) (table 2). The number needed to treat to harm is 20.

View this table: [in this window] [in a new window]   Table 2 Primary end point of both trials: major complications. Values are numbers (percentages) of participants

 

We found no difference in the complication rates after the two procedures in the vaginal trial (mean difference 0.3%, -5.2% to 5.8%, P = 0.92; odds ratio 0.97, 0.52 to 1.81), the number needed to treat to harm is 333. However, the confidence interval is wide and includes harmful and beneficial effect of clinical relevance.

Secondary outcomes
Minor complications—In the abdominal trial the percentage of patients who had at least one minor complication was 27.1% in patients undergoing abdominal hysterectomy compared with 25.2% for laparoscopic hysterectomy, and for the vaginal trial 27.9% in patients undergoing vaginal hysterectomy and 23.2% for laparoscopic hysterectomy (table 3). We found no evidence to show that there was any difference in minor complication rates between the procedures in any of the comparisons.

View this table: [in this window] [in a new window]   Table 3 Secondary end points of both trials: minor complications. Values are numbers (percentages) of patients

 

Additional pathology found during the operation—In the abdominal trial additional pathology was reported in 12.7% (373/292) of patients undergoing abdominal hysterectomy compared with 22.6% (132/584) undergoing laparoscopic hysterectomy, (mean difference -9.9%, -15.4 to -4.4%, P = < 0.01)). In the vaginal trial the rates were 4.8% (8/168) for vaginal hysterectomy and 16.4% (53/336) for laparoscopic hysterectomy (mean difference -11.6%, -17.7% to -5.5%, P = < 0.01)). The main additional findings were adhesions, endometriosis, and fibroids.

Pain—In the abdominal trial abdominal hysterectomy was more painful than laparoscopic hysterectomy (adjusted mean pain score 3.9 abdominal hysterectomy, 3.5 laparoscopic hysterectomy; mean difference 0.4, 0.09 to 0.7, P = 0.01). We found no evidence of a difference in pain scores in the vaginal trial.

Length of surgery and length of stay—In the abdominal trial the median length of stay after abdominal hysterectomy was four days and three days after laparoscopic hysterectomy, but was three days in both arms of the vaginal trial. We undertook no formal statistical testing, but these differences may be clinically important.

Quality of life—All procedures were associated with improvements in the physical and mental components of SF-12, body image scale, and aspects of sexual activity at four months compared with baseline (see bmj.com). These changes were maintained or improved further at 12 months. In the abdominal trial we found a highly significant difference in the physical component summary score of the SF-12 at six weeks between abdominal hysterectomy and laparoscopic hysterectomy. We also found highly significant differences in body image scale between abdominal hysterectomy and laparoscopic hysterectomy in the abdominal trial at six weeks, a borderline significant difference at four months but no difference at 12 months. According to the sexual activity questionnaire "habit" scores in this trial were higher at six weeks after laparoscopic hysterectomy than after abdominal hysterectomy (-0.3, 0.1 to 0.6, P 0.01). We found no evidence of a difference in quality of life at any time point in the vaginal trial.

Discussion

The results of the two trials confirm the advantages to the patient of avoiding a laparotomy incision. In the abdominal trial laparoscopic hysterectomy was associated with a clinically relevant higher incidence of major complications and took longer to perform. These disadvantages were offset by patient friendly benefits of less pain, shorter hospital stay, quicker recovery, and improved quality of life indicators in the short term. The comparison between laparoscopic and vaginal methods was underpowered but did not show any significant differences between the two methods, except that vaginal hysterectomy was performed in a shorter time.

Limitations of the study
Abdominal and vaginal hysterectomy are both commonly performed; 564 865 were performed in the United States²⁰ and more than 65 000 in the United Kingdom in 1995.²¹ Despite this large number of potential patients we anticipated that recruiting sufficient numbers of surgeons and patients to this trial would be difficult. Most gynaecologists have well defined indications for each approach, and few would feel comfortable in randomising all patients to any approach. To allow each surgeon to maintain equipoise and maximise recruitment we designed this study as two separate but parallel trials. For similar reasons we excluded some conditions, such as large fibroids, for which most surgeons would prefer to undertake an abdominal hysterectomy, and major degrees of uterovaginal prolapse, for which almost all would undertake a vaginal

What is already known on this topic Hysterectomy is one of the most often performed of all major surgical operations It has traditionally been performed by either the vaginal or the abdominal method Either method has advantages and disadvantages, but the indications for each remain controversial and have never been compared in a randomised controlled trial More recently a third method of hysterectomy has been developed, the laparoscopic hysterectomy What this study adds The results confirm the advantages to the patient of avoiding a laparotomy incision Laparoscopic hysterectomy was associated with a clinically relevant higher incidence of major complications and took longer to perform than the abdominal method With laparoscopic hysterectomy patients have less pain, shorter hospital stay, quicker recovery, and improved quality of life indicators in the short term Vaginal hysterectomy is quicker than laparoscopic hysterectomy hysterectomy. This pragmatic approach excluded many patients and several of the most important indications for hysterectomy. These decisions will reduce the generalisability of the study. We believe, however, that the design maximised recruitment of surgeons and patients and concentrated the study where the indications as to preferred method were least clear.

Including unintended laparotomy as a major complication caused debate in the trial's steering committee. It represented the second most common major complication, and a large proportion of these patients did not have any other complication. It could be considered that such conversions represented prudent surgery rather than a major complication. Excluding them would have substantially reduced the overall complication rates associated with both laparoscopic hysterectomy and vaginal hysterectomy. We think that on balance they represented a failure of planned procedure and should be considered as major complications.

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A complete list of members of the study group is on bmj.com

This is the abridged version of an article that was posted on bmj.com on 7 January 2004: http://bmj.com/cgi/doi/10.1136/bmj.37984.623889.F6

We thank all members of the trial steering committee, data monitoring, and ethics committee for their hard work in the conduct of this trial, and Derek Tuffnell for his assistance with the independent clinical review of the research data. We thank the Simon Foundation and the University of Teesside for their support of the principal investigator as Simon professor of gynaecology during this study. In addition, the trial would not have been possible without the valued contributions of the women who were willing to give their time and share their experiences to extend our knowledge in this area. The eVALuate trial including the full data analysis is reported in a submission to the HTA Monograph Series.

Contributors: See bmj.com

Funding: This study was supported by a grant from the National Health Service Research and Development Health Technology Assessment Programme. The views and opinions expressed in the paper do not necessarily reflect those of the NHS Executive.

Competing interests: None declared.

Ethical approval: The trials received approval from the multicentre research ethics committee and the local research ethics committee.

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(Accepted 1 September 2003)

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