Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH™

Objective: The objective of this multicenter, randomized study was to investigate the efficacy of the hydrophilic resorbable film PREVADH (TM) in preventing postoperative adhesions following myomectomy. Study design: Women scheduled for laparotomic myomectomy with intramural and/or subserous myomas of >60 mm in diameter, and who wished to preserve fertility, were eligible. Patients were randomized immediately prior to abdominal wall closure to receive either hydrophilic resorbable film applied directly to the incisions (P-Group, n = 33) or 500 mL Ringer's lactate solution instilled into the pelvic cavity (R-Group, n = 28). Incidence, severity, and extent of postoperative adhesions to the uterine incisions and adnexal and abdominopelvic adhesions were assessed during second-look laparoscopy 10-20 weeks after the initial surgery. Unedited videotapes of this second-look procedure were reviewed by two blinded independent surgeons. Results: Fifty-four patients (P-Group, n = 28; R-Group, n = 26) underwent second-look laparoscopy. Significantly fewer P-Group patients developed adhesions to uterine incisions than R-Group patients (43% vs. 92%, P = 0.001). Adhesions, which were confirmed by independent reviewers, were found in significantly fewer P-Group sites than R-Group sites (29% vs. 76%, P = 0.001). No serious adverse events related to the barriers used or adhesion-related complications were reported in either group. Conclusion: The hydrophilic resorbable anti-adhesion film PREVADH (TM) significantly reduced adhesion incidence and severity after laparotomic myomectomy. (C) 2014 Elsevier Ireland Ltd. All rights reserved.