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

By R. Garry, J. Fountain, S. Mason, J. Hawe, V. Napp, J. Abbott, R. Clayton, G. Phillips, M. Whittaker, R. Lilford, S. Bridgman and J. Brown

Abstract

OBJECTIVE: To compare the effects of laparoscopic hysterectomy\ud and abdominal hysterectomy in the abdominal trial, and\ud laparoscopic hysterectomy and vaginal hysterectomy in the\ud vaginal trial.\ud \ud \ud DESIGN: Two parallel, multicentre, randomised trials.\ud Setting 28 UK centres and two South African centres.\ud Participants 1380 women were recruited; 1346 had surgery;\ud 937 were followed up at one year.\ud \ud PRIMARY OUTCOME: outcome Rate of major complications.\ud \ud RESULTS: In the abdominal trial laparoscopic hysterectomy was\ud associated with a higher rate of major complications than\ud abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference\ud 4.9%, 95% confidence interval 0.9% to 9.1%) and the number\ud needed to treat to harm was 20. Laparoscopic hysterectomy\ud also took longer to perform (84 minutes v 50 minutes) but was\ud less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and\ud resulted in a shorter stay in hospital after the operation (3 days\ud v 4 days). Six weeks after the operation, laparoscopic\ud hysterectomy was associated with less pain and better quality of\ud life than abdominal hysterectomy (SF-12, body image scale, and\ud sexual activity questionnaires).\ud In the vaginal trial we found no evidence of a difference in\ud major complication rates between laparoscopic hysterectomy\ud and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference\ud 0.3%, − 5.2% to 5.8%), and the number needed to treat to harm\ud was 333.We found no evidence of other differences between\ud laparoscopic hysterectomy and vaginal hysterectomy except\ud that laparoscopic hysterectomy took longer to perform (72\ud minutes v 39 minutes) and was associated with a higher rate of\ud detecting unexpected pathology (16.4% v 4.8%, P = < 0.01).\ud However, this trial was underpowered.\ud \ud \ud CONCLUSIONS: Laparoscopic hysterectomy was associated with a\ud significantly higher rate of major complications than abdominal\ud hysterectomy. It also took longer to perform but was associated\ud with less pain, quicker recovery, and better short term quality of\ud life. The trial comparing vaginal hysterectomy with laparoscopic\ud hysterectomy was underpowered and is inconclusive on the rate\ud of major complications; however, vaginal hysterectomy took less\ud time

Year: 2004
OAI identifier: oai:eprints.whiterose.ac.uk:165

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