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

被引:402
作者
Garry, R [1 ]
Fountain, J
Mason, S
Napp, V
Brown, J
Hawe, J
Clayton, R
Abbott, J
Phillips, G
Whittaker, M
Lilford, R
Bridgman, S
机构
[1] Univ Western Australia, King Edward Mem Hosp, Dept Obstet & Gynaecol, Perth, WA 6008, Australia
[2] Univ Leeds, No & Yorkshire Clin Trials & Res Unit, Leeds LS2 9NG, W Yorkshire, England
[3] James Cook Univ Hosp, Middlesbrough TS4 3BW, Cleveland, England
[4] Univ New S Wales, Royal Womens Hosp, Randwick, NSW 2031, Australia
[5] St James Univ Hosp, Leeds LS9 7TF, W Yorkshire, England
[6] Univ Birmingham, Dept Epidemiol & Publ Hlth, Birmingham B15 2UP, W Midlands, England
[7] Newcastle Lyme Primary Care Trust, Newcastle Under Lyme ST5 7NJ, Staffs, England
来源
BRITISH MEDICAL JOURNAL | 2004年 / 328卷 / 7432期
关键词
D O I
10.1136/bmj.37984.623889.F6
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 = 0.0 1) 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 6.3%, - 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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收藏
页码:129 / 133
页数:7
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