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

Ray Garry, professor of clinical gynaecology1, Jayne Fountain, medical statistician2, Su Mason, principal research fellow2, Jeremy Hawe, research fellow3, Vicky Napp, head of trial co-ordination2, Jason Abbott, deputy director, endo-gynaecology4, Richard Clayton, research fellow5, Graham Phillips, consultant obstetrician and gynaecologist3, Mark Whittaker, research fellow5, Richard Lilford, professor of clinical epidemiology6, Stephen Bridgman, director of public health7, Julia Brown, head of unit2

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 Director of Public Health, Newcastle under Lyme, Primary Care Trust, Newcastle-under-Lyme, Stafforshire ST5 7NJ

Correspondence to: R Garry rgarry{at}obsgyn.uwa.edu.au

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.


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