White Rose University Consortium logo
University of Leeds logo University of Sheffield logo York University logo

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

Garry, R., Fountain, J., Mason, S., Hawe, J., Napp, V., Abbott, J., Clayton, R., Phillips, G., Whittaker, M., Lilford, R., Bridgman, S. and Brown, J. (2004) The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ, 328 (7432). pp. 129-133. ISSN 0959-8138

Full text available as:
[img]
Preview
Text
masons1.pdf
Available under licence : See the attached licence file.

Download (185Kb)

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: 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.

Item Type: Article
Copyright, Publisher and Additional Information: © 2004 BMJ Publishing Group Ltd
Institution: The University of Leeds
Academic Units: The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Academic Unit of Epidemiology and Health Services Research (Leeds)
Depositing User: Repository Officer
Date Deposited: 13 Jun 2005
Last Modified: 04 Jun 2014 18:16
Published Version: http://bmj.com/cgi/content/full/328/7432/129
Status: Published
Refereed: Yes
Identification Number: 10.1136/bmj.37984.623889.F6
URI: http://eprints.whiterose.ac.uk/id/eprint/165

Actions (login required)

View Item View Item