Michel J Canis1, Grégory Triopon2, Emile Daraï3, Patrick Madelenat4, Jean LeVêque5, Pierre Panel6, Hervé Fernandez7, Alain Audebert8, Philippe Descamps9, Nicolas Castaing10, Horace Roman11, Arnaud Fauconnier12, Jean Louis Benifla13. 1. CHU Estaing, Department of Gynecologic and Obstetric Surgery, Clermont Ferrand, France. Electronic address: mcanis@chu-clermontferrand.fr. 2. CHU Carémeau, Department of Gynecologic and Obstetric Surgery, Nîmes, France. 3. AP-HP, Hôpital Tenon, Department of Gynecologic and Obstetric Surgery, Université Pierre et Marie Curie Paris 6, France. 4. AP-HP, Hôpital Bichat, Department of Gynecologic and Obstetric Surgery, Paris, France. 5. CHU, Hôpital Sud, Department of Gynecologic and Obstetric Surgery, Rennes, France. 6. Centre Hospitalier de Versailles-Hôpital Mignot, Department of Gynecologic and Obstetric Surgery, Le Chesnay, France. 7. AP-HP, Hôpital Antoine Béclère, Department of Gynecologic and Obstetric Surgery, Clamart, France. 8. Polyclinique du Tondu, Department of Gynecologic and Obstetric Surgery, Bordeaux, France. 9. CHU d'Angers, Department of Gynecologic and Obstetric Surgery, Angers, France. 10. Centre Hospitaliers des quatre villes, Department of Gynecologic and Obstetric Surgery, Sèvres, France. 11. CHU de Rouen, Department of Gynecologic and Obstetric Surgery, Rouen, France. 12. CHI Poissy Saint-Germain en Laye, Department of Gynecologic and Obstetric Surgery, Research Unit EA7285, University Versailles Saint-Quentin en Yvelines Poissy, France. 13. AP-HP, Hôpital Armand Trousseau, Department of Gynecologic and Obstetric Surgery, Université Pierre et Marie Curie, Paris, France.
Abstract
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).
RCT Entities:
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).
Authors: Chang Hyung Lee; Hongbeom Kim; In Woong Han; Suh Min Kim; Beom Seok Kwak; Yong Hae Baik; Young Jin Park; Min Gu Oh Journal: Ann Hepatobiliary Pancreat Surg Date: 2016-11-30