EVALUATE hysterectomy trial: a multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy

Garry R, Fountain J, Brown J, Manca A, Mason S, Sculpher M, et al
Record ID 32004000333
English
Authors' objectives:

The objective of the study was to test the null hypothesis of no significant difference between laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH) and vaginal hysterectomy (VH) with regard to each of the outcome measures of the trial, and also to assess the cost-effectiveness of the alternative procedures.

Authors' results and conclusions: Compared with AH, LH was associated with a higher rate of major complications (11.1 versus 6.2%, p = 0.02), less postoperative pain (visual analogue scale score of 3.51 versus 3.88, p = 0.01) and shorter hospital stay (3 versus 4 days), but took longer to perform (84 versus 50 minutes). Securing the ovarian pedicles with laparoscopic sutures was used in only 7% of cases but was associated with 25% of the complications. At the 6 weeks postoperative point, ALH was associated with a significantly better physical component of the health survey questionnaire (SF-12), better body image scale (BIS) scores and a significantly increased frequency of sexual intercourse than AH. These differences were not observed at either 4 months or 12 months after surgery. There were no significant differences in any measured outcome between LH and VH except that VLH took longer to perform (72 versus 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4 versus 4.8%, p < 0.001).
Authors' recommendations: ALH is associated with a significantly higher risk of major complications and takes longer to perform than AH. ALH is, however, associated with less pain, quicker recovery and better short-term QoL after surgery than AH. The cost-effectiveness of ALH is finely balanced and depends on the threshold value the NHS attaches to an additional QALY and the error probability that the system is willing to accept in making its decision. Cost-effectiveness is also influenced by the balance of reusable equipment versus disposable consumables used during ALH. Individual surgeons must determine the optimum balance between patient-orientated benefits and the risk of severe complications. The clinical results from the vaginal trial were inconclusive as the study was under-powered. VLH was not cost-effective relative to VH.
Authors' methods: Randomised controlled trial
Details
Project Status: Completed
URL for project: http://www.hta.ac.uk/964
Year Published: 2004
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Cost-Benefit Analysis
  • Female
  • Hysterectomy, Vaginal
  • Length of Stay
  • Outcome and Process Assessment, Health Care
  • Pain Measurement
  • Patient Satisfaction
  • Pregnancy
  • Quality of Life
  • Treatment Outcome
  • Gynecology
  • Hysterectomy
  • Intraoperative Complications
  • Laparoscopy
  • Postoperative Complications
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: 2009 Queen's Printer and Controller of HMSO
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