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

Abstract

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

Material and methods: 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.

Results: 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.

Conclusion: 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.