Surgery on trial: An account of clinical trials evaluating operations

Background. The objective of this study was to review published clinical trials to determine the level of compliance with issues relevant to operations. Methods. We evaluated 10 ?methodologic criteria in 186 trials that were published in 10 prestigious journals between January 1986 and December 1995. Results. One quarter of the trials failed to provide a clear account of the operative technique, 34 % of the trials did not adequately detail the adverse events that occurred after operation, and 40% of the trials neglected to declare the nature and success of the follow-up of patients after the operation. Only 35 % of the trials indicated that there was an attempt to standardize either the surgical procedure or perioperative care. In addition, less than 20 % of the trials declared a method for assessing compliance with the surgical protocol or commented on the use of resources during the perioperative period Conclusions. Greater attention needs to be paid to the specific issues that arise when operations are evaluated in clinical trials.