French randomized trials in general and digestive surgery over the last decade.

Study aim: To study the characteristics of randomized trials published by g eneral 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 charac teristics of the trials and their methodology were assessed. At the same ti me, a survey was conducted among authors to assess the impact of applicatio n of the Huriet-Serusclat law (ethics related to the protection of individu als 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 particul ar step of the procedure (anastomosis, drainage, etc). Most trials (83%) we re published in English language journals. The 18 trials with a good method ological quality mainly had a multicentre design (n = 16). The survey showe d that 10 trials were conducted prior to the publication of Huriet-Seruscla t law and that 14 trials were conducted in compliance with this law. Conclusion: This study revealed the large number of well designed multicent re trials in France. But most trials assessed technical steps of the surgic al procedures. Application (without prerequisite) of the Huriet-Serusclat l aw could probably explain the rarity and the difficulties of conducting tri als comparing two different procedures or a surgical with a medical treatme nt. (C) 2000 Editions scientifiques et medicales Elsevier SAS.