A randomised comparison and economic evaluation of laparoscopic-assisted hysterectomy and abdominal hysterectomy



In your recent Editor's Choice1, you conclude that “as an extra two-day stay in hospital and a week longer off work may not matter to a woman having a hysterectomy, abdominal hysterectomy is here to stay”. This conclusion is based primarily on the study by Lumsden et al.2 in the same issue. This study, although from highly respected institutions with a long track record of excellent research, is flawed methodologically, in a manner which calls into question the conclusions you have endorsed. The problem, as always, is in the detail.

The planned study size of 240 was calculated to allow an 80% chance of detecting a 15% difference in overall complication rates between abdominal and laparoscopic-assisted vaginal hysterectomy. In the event, even this fairly small study size was not achieved and the 200 women included in the study demonstrated a difference in complication rates of only 7% in favour of the laparoscopic-assisted arm. Most of the complications noted were of the ‘minor’ variety and probably of insufficient importance to determine the optimum mode of hysterectomy. The relative rate of major complications is of much more relevance when choosing the preferred surgical method. Such major complications are fortunately much less common and obviously require a much larger sample size to detect significant differences. This study was seriously underpowered to detect such changes.

In the absence of significant differences in complication rates, the authors make much of the apparent cost differential between the two techniques. The technique of laparoscopic-assisted vaginal hysterectomy in this study profoundly biases this calculation. The use of stapling devices to secure the uterine pedicles is the most expensive way of performing laparoscopic-assisted vaginal hysterectomy. Very few centres of laparoscopic gynaecological surgery recommend such costly equipment, which was designed for intestinal anastomosis, when much less expensive and simpler alternatives are now readily available. The article points out that when the cost of such devices was excluded, the remaining cost differential between the techniques was a statistically insignificant £73. For this sum, each woman in this study having a laparoscopic-assisted vaginal hysterectomy leave hospital two days earlier after a procedure associated with fewer complications, than if they had had a total abdominal hysterectomy.

There may indeed be advantages of total abdominal hysterectomy over laparoscopic-assisted vaginal hysterectomy, but this study was too small to demonstrate these. Much larger studies are required to determine the relative risks and benefits of these alternative operations. Any conclusions based on this small study may be premature and inappropriate. The results of a national prospective survey of the outcomes of more than 37,000 hysterectomies (the VALUE Study) and of a national multicentre randomised trial of almost 1400 abdominal, vaginal and laparoscopic-assisted hysterectomies (the EVALUATE Study) will soon be available. I believe important clinical judgements about the relative place of each of these procedures should be deferred until data from studies of sufficient size to provide statistically meaningful results are available.