[French randomized trials in general and digestive surgery in the last decade]

To study the characteristics of randomized trials published by general and digestive French surgeons over the last decade.

An extensive electronic and manual literature search was performed. Trials published as original articles compared two surgical techniques or a surgical procedure with a nonsurgical treatment. The characteristics of the trials and their methodology were assessed. At the same time, a survey was conducted among authors to assess the impact of application of the Huriet-Sérusclat law (ethics related to the protection of individuals subjected to bioclinical research) on the conduct of the trial.

Forty trials (including 22 multicentre trials) were found. Twelve trials (30%) addressed a key-question and twenty (50%) addressed a particular step of the procedure (anastomosis, drainage, etc). Most trials (83%) were published in English language journals. The 18 trials with a good methodological quality mainly had a multicentre design (n = 16). The survey showed that 10 trials were conducted prior to the publication of Huriet-Sérusclat law and that 14 trials were conducted in compliance with this law.

This study revealed the large number of well designed multicentre trials in France. But most trials assessed technical steps of the surgical procedures. Application (without prerequisite) of the Huriet-Sérusclat law could probably explain the rarity and the difficulties of conducting trials comparing two different procedures or a surgical with a medical treatment.