BMJ  2004;328:643 (13 March), doi:10.1136/bmj.328.7440.643

Letter

Results of eVALuate study of hysterectomy techniques

High rate of complications needs explanation

The first 150 words of the full text of this article appear below.

EDITOR—Garry et al conducted two parallel randomised studies to evaluate the effects of laparoscopic hysterectomy compared with abdominal and vaginal hysterectomy.¹ The major bias of their method led them to the wrong conclusion.

The primary end point was the occurrence of major complications, which was as high as 11.1% in the laparoscopic hysterectomy group. This rate is totally unacceptable and could be explained by major bias.

Firstly, 43 gynaecologists from 30 centres took part. The mean number of laparoscopic hysterectomies (n = 584) per gynaecologist was therefore 13 over four years.

Secondly, the experience of the 43 gynaecologists most certainly differed from centre to centre. The rate of complications is not analysed according to the gynaecologists' experience.

Thirdly, the learning curve greatly exceeds 25 cases.² In our series of 1600 laparoscopic hysterectomies, the rate of major complications was 0.6% after laparoscopic subtotal hysterectomy and 2% after laparoscopic hysterectomy. . . . [Full text of this article]

donnez@gyne.ucl.ac.be

Department of Gynaecology, Catholic University of Louvain, Cliniques Universitaires Saint-Luc, Avenue Hippocrate, 10-B-1200 Brussels, Belgium

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

Ray Garry, Jayne Fountain, Su Mason, Jeremy Hawe, Vicky Napp, Jason Abbott, Richard Clayton, Graham Phillips, Mark Whittaker, Richard Lilford, Stephen Bridgman, and Julia Brown
BMJ 2004 328: 129. [Abstract] [Full Text] [PDF]

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