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™ in preventing postoperative adhesions following myomectomy.

STUDY

DESIGN

Women scheduled for laparotomic myomectomy with intramural and/or subserous myomas of >60mm 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 500mL 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™ significantly reduced adhesion incidence and severity after laparotomic myomectomy.

CLINICAL TRIAL REGISTRATION: NCT01388907 (www.clinicaltrials.gov).