Why laparoscopic adhesiolysis should not be the victim of a single randomized clinical trial.
Randomized controlled trials may provide erroneous conclusions when the null hypothesis is not rejected because of insufficient analysis statistical power. The authors dispute the conclusion of a randomized controlled trial that compared chronic pain relief rates following laparoscopic adhesiolysis and diagnostic laparoscopy and recommended abandoning laparoscopic adhesiolysis. In the trial, the observed difference between pain rates (15%) was inferior to that expected (35%). On the basis of this result, we calculated the 90% confidence interval of the true difference, whose limits of -1% and 31% were found to fall outside the predetermined equivalency interval (-10% to 10%). The trial should therefore not have concluded that the 2 surgical procedures were equivalent. By doing so, it is likely that numerous surgeons have abandoned laparoscopic adhesiolysis on the basis of this statement. In any randomized trial, a calculation of statistical power is required each time that the null hypothesis cannot be rejected.
Roman
Horace
H
Department of Pediatric Epidemiology, Medical University of South Carolina, Charleston, SC 29425, USA. horace.roman@gmail.com
Hulsey
Tara F
TF
Marpeau
Loïc
L
Hulsey
Thomas C
TC
D002908:Chronic Disease; D005260:Female; D006801:Humans; D010535:Laparoscopy; D017699:Pelvic Pain / Q000601:surgery*; D011183:Postoperative Complications / Q000601:surgery*; D016032:Randomized Controlled Trials as Topic; D000267:Tissue Adhesions / Q000601:surgery*