Analysis of randomized controlled trials in laparoscopic surgery.

BACKGROUND

Randomized controlled studies of surgical procedures are difficult, but can be done to acceptable standards. There are few published objective assessments of such trials.

METHODS

The original articles that involved a randomized controlled trial including at least one laparoscopic procedure were reviewed and evaluated with special interest in their methodology. An assessment form containing 11 generic questions and three additional criteria (assessment of quality of life, cost analysis and laparoscopic experience required) was used. Forty trials were retrieved including 12 on cholecystectomy, 12 on hernia repair and 12 on appendicectomy. Each trial was scored by two assessors.

RESULTS

The agreement among the two independent assessors was very good. Six of the trials were well conducted but 22 had a poor score. The trials on cholecystectomy were scored the best in contrast to those on hernia repair or appendicectomy. Few trials provided an adequate prospective calculation of the sample size, an unbiased assessment of endpoints, evaluation of the quality of life and a study of the economic aspects.

CONCLUSION

Readers should be cautious when interpreting the results of some of these trials and their impact on daily surgical practice.