REDUCTION OF ADHESIONS AFTER UTERINE MYOMECTOMY BY SEPRAFILM MEMBRANE(HAL-F) - A BLINDED, PROSPECTIVE, RANDOMIZED, MULTICENTER CLINICAL-STUDY

Objective: To assess the safety and efficacy of Seprafilm (HAL-F), Bio resorbable Membrane, (Genzyme Corporation, Cambridge, MA) in reducing the incidence, severity, extent, and area of uterine adhesions after m yomectomy. Design: Prospective, randomized, blinded, multicenter study . Adhesion reduction was assessed by an independent, blinded, gynecolo gic surgeon who reviewed videotapes of each patient's second-look lapa roscopy. Setting: Nineteen institutions across the United States. Pati ent(s): One hundred twenty-seven women undergoing uterine myomectomy w ith at least one posterior uterine incision greater than or equal to 1 cm in length. Intervention(s): Patients were randomized to treatment with Seprafilm or to no treatment at the completion of the myomectomy. Main Outcome Measure(s): The incidence, severity, extent, and area of uterine adhesions at second-look laparoscopy. Result(s): The incidenc e, measured as the mean number of sites adherent to the uterine surfac e, was significantly less in treated patients (4.98 +/- 0.52 [mean +/- SEM] sites) than in no treatment patients (7.88 +/- 0.48 sites) as we re the mean uterine adhesion severity scores (1.94 +/- 0.14 versus 2.4 3 +/- 0.10; treatment versus no treatment, respectively), mean extent scores (1.23 +/- 0.12 versus 1.68 +/- 0.10), and mean area of adhesion s (13.2 +/- 1.67 versus 18.7 +/- 1.66 cm(2)). No adverse events occurr ed that were judged to be related to the use of Seprafilm. Conclusion( s): In this multicenter study, treatment of patient;s after myomectomy with Seprafilm significantly reduced the incidence, severity, extent, and area of postoperative uterine adhesions. Additionally, Seprafilm treatment was not associated with an increase in postoperative complic ations.