The operative laparoscopy debate: technology assessment or statistical Jezebel?

Laparoscopic surgery has been severely criticized recently because few controlled studies have been performed to show that specific operations are better when carried out endoscopically rather than by using an open technique. Critics have also claimed that only randomized clinical trials can show these procedures to be effective, and they have not been carried out because surgical and medical therapy are held to different standards. These criticisms are examined and discussed in this paper, and many of the arguments are shown to be invalid. Although bias is an undeniable concern in retrospective studies, the scope of randomized clinical trials is limited by the inability to randomize or blind treatment, and their validity is restricted by the failure to select patients randomly for study. Therefore, whatever the limitations of retrospective studies, there is frequently no option but to adopt a research strategy other than a randomized trial, and some possibilities are discussed.