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

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.

Implementing an Advanced Laparoscopic Procedure by Monitoring with a Visiting Surgeon

“…Compared with these numbers, the major complication rate in the present study was relatively low during the learning curve (3.6%), indicating that the presence of a visiting surgeon prevents complications during the learning curve. After the learning curve, our complication rate (6.0%) was favorable compared with that of Garry et al [17], the only other prospective multicenter trial, but higher compared with the other 3 studies. This might be explained in that these 3 studies were retrospective singlecenter trials and spanned a longer time and larger number of patients.…”

“…Our Table 3 Characteristics of 166 study patients intraoperative complication rate during the learning curve was 2.4% (2 of 83 procedures), and after the learning curve was 3.6% (3 of 83 procedures); postoperative major complications during the learning curve were 1.2%, and after the learning curve were 2.4%. Garry et al [17] demonstrated a similar complication rate in the eVALuate trial (7.2% and 7.1% after exclusion of conversion to laparotomy). However, in contrast to the present trial, in which surgical competence was measured qualitatively, Garry et al [17] defined surgical competence by the number of previously completed procedures, with a cutoff of 25 procedures.…”

“…Garry et al [17] demonstrated a similar complication rate in the eVALuate trial (7.2% and 7.1% after exclusion of conversion to laparotomy). However, in contrast to the present trial, in which surgical competence was measured qualitatively, Garry et al [17] defined surgical competence by the number of previously completed procedures, with a cutoff of 25 procedures. Compared with these numbers, the major complication rate in the present study was relatively low during the learning curve (3.6%), indicating that the presence of a visiting surgeon prevents complications during the learning curve.…”

“…The objective of the study was to determine whether it was feasible to implement an advanced laparoscopic procedure in established gynecologists' practices, with a major complication rate during the learning curve that was comparable to that of a prospective multicenter study in the literature (7%) [17]. The major complication rate in the present study was 4.8% (95% CI, .002-.09) in 166 patients, 3.6% during the learning curve, and 6.0% thereafter.…”

“…Major complication rates ranging from 1.2% to 11.1% have been reported in studies of LH [7,8,10,17,18]. Wattiez et al [10] noted that major complications occurred in 39 of 695 LH procedures (5.6%) performed by a surgeon in the first 6 years compared with 12 in 953 LH procedures (1.3%) in the 3 years thereafter.…”