Results of eVALuate study of hysterectomy techniques
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《英国医生杂志》
EDITOR—Given the pre-eminent role of gynaecologists in developing both operative laparoscopy and randomised trials, we were astonished that we might need a gastrointestinal surgeon in our team. Many of our team were, however, intuitively empathetic with Atkinson's concern that preoperative conversion should not be considered a major complication. To exclude patients who did not receive the planned treatment would alter the complication rates and represent a post-randomisation selection bias in favour of laparoscopic hysterectomy. We therefore classified such cases as failures of the approach and thus major complications. Like Atkinson, we consider conversion to laparotomy sometimes to be prudent and the best option.
Saunders has overlooked one of the virtues of randomisation. We could not insist on a single standard anaesthetic and analgesic regimen. We could, however, ensure that in each centre the same regimen was used for both arms of each trial. As the randomisation process was rigorous, the effect of confounding variables such as the anaesthetic used should be equally distributed in each group and any effect on results essentially eliminated. We are confident in the integrity of the data showing that laparoscopic hysterectomy is associated with less pain than abdominal hysterectomy.
Canis et al and Donnez et al think that we undertook the study too early in our collective experience. However, the learning curve of Canis et al was 600 cases, and Donnez et al evaluated their results only after 1000 cases. Their definitive results represent the best in the world and are the gold standard to strive for. Our primary aim was not to collect the results of such "super surgeons" but to determine the role of laparoscopic hysterectomy in routine practice.
We asked, "Are the advantages of laparoscopic surgery so great that all gynaecologists should be encouraged to undertake this approach?" The answer seems to be no, or at least not yet. The benefits of laparoscopic hysterectomy over the abdominal approach are real but are of practical value only if they can be achieved with an acceptable complication rate. Canis et al and Donnez et al show that this can be achieved, but to match the best results may require the development of many centres of laparoscopic excellence similar to theirs.
Saunders has overlooked one of the virtues of randomisation. We could not insist on a single standard anaesthetic and analgesic regimen. We could, however, ensure that in each centre the same regimen was used for both arms of each trial. As the randomisation process was rigorous, the effect of confounding variables such as the anaesthetic used should be equally distributed in each group and any effect on results essentially eliminated. We are confident in the integrity of the data showing that laparoscopic hysterectomy is associated with less pain than abdominal hysterectomy.
Canis et al and Donnez et al think that we undertook the study too early in our collective experience. However, the learning curve of Canis et al was 600 cases, and Donnez et al evaluated their results only after 1000 cases. Their definitive results represent the best in the world and are the gold standard to strive for. Our primary aim was not to collect the results of such "super surgeons" but to determine the role of laparoscopic hysterectomy in routine practice.
We asked, "Are the advantages of laparoscopic surgery so great that all gynaecologists should be encouraged to undertake this approach?" The answer seems to be no, or at least not yet. The benefits of laparoscopic hysterectomy over the abdominal approach are real but are of practical value only if they can be achieved with an acceptable complication rate. Canis et al and Donnez et al show that this can be achieved, but to match the best results may require the development of many centres of laparoscopic excellence similar to theirs.