Randomiserte kliniske studier (RCT) innen kirurgisk og medisinsk metodeutvikling. Eksemplifisert ved laparoskopisk kolecystektomi.

Abstract

Abstract

The objective of this survey was to evaluate the implementation-process of a new surgical procedure by examining the impact of, the results and the methodology of some of the earliest randomised controlled trials comparing laparoscopic and mini-laparotomy cholecystectomy.

Laparoscopic cholecystectomy (LC) was introduced in France in 1987, its popularity spread rapidly the next few years and it was soon the method of choice for cholecystectomy in many western countries. LC was supported to be superior to the open approach based on observational studies. The first randomised controlled studies comparing laparoscopic with the traditional conventional and the relatively new small-incision (MC) approach were published late in 1992. The results confirmed the suggestion that LC had distinct benefits compared with MC or open cholecystectomy (OC). Later, it has been verified that MC is a better approach than OC, the focus in this survey is therefore on MC rather than on OC.

The earliest studies comparing LC and MC found that patients undergoing LC had a shorter hospital stay, less pain and a shorter convalescense. Later studies showed no clear advantage with either method. Two meta-analyses comparing LC and MC found a longer operative time and a slight shorter hospital stay in the laparoscopic group.

The introduction of LC was not evidence based, its fast diffusion was influenced by factors as patients demands, surgeons beliefs, media, and commercial interests. The earliest randomised controlled trials had many methodological shortcomings that could bias the results in favour of laparoscopy. These methodological deficiencies reflect some general challenges in evaluating surgical methods by randomised controlled trials. It has been recommended that surgical methods, as drugs, should be evaluated by randomised controlled trials in an earlier stage of implementation.