Clinical Trial Design for Evaluation of Treatments Purported to Prevent Postsurgical Adhesions
Performing clinical trials to evaluate different treatments purported to reduce postoperative pelvic adhesions is intrinsically difficult. These trials typically involve gynecologic surgical procedures and require early second-look laparoscopic evaluation,1–6 which is an expensive undertaking. There is a diverse array of therapeutic strategies currently under investigation as well as a wide variety of clinical situations in which postsurgical adhesions may occur. To further complicate the matter, there are usually limited resources available for investigation of new technologies and substantial economic pressures to rapidly determine efficacy. Under these circumstances, it is not surprising that the usual approach is to extract the maximum information from a clinical trial at minimal cost. However, unless a proper experimental design is employed, the entire effort may be wasted without ever testing the hypothesis that the treatment is effective. This leads to the possibility that an ineffective or potentially hazardous therapy might be deemed clinically useful or an effective therapy might be discarded. The goal for a clinical trial is to design it so that a positive result is sufficient to change physician behavior. Few, if any, of the currently available trials attain this level of scientific excellence.
KeywordsCellulose Dextran Arena Infertility Endometriosis
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