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.


METHODS
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.


CONCLUSIONS
The hydrophilic resorbable anti-adhesion film PREVADH™ significantly reduced adhesion incidence and severity after laparotomic myomectomy.


BACKGROUND
NCT01388907 (www.clinicaltrials.gov).
CHU Estaing, Department of Gynecologic and Obstetric Surgery, Clermont Ferrand, France. Electronic address: mcanis@chu-clermontferrand.fr.
Michel J
MJ
Canis
CHU Carémeau, Department of Gynecologic and Obstetric Surgery, Nîmes, France.
Grégory
G
Triopon
AP-HP, Hôpital Tenon, Department of Gynecologic and Obstetric Surgery, Université Pierre et Marie Curie Paris 6, France.
Emile
E
Daraï
AP-HP, Hôpital Bichat, Department of Gynecologic and Obstetric Surgery, Paris, France.
Patrick
P
Madelenat
CHU, Hôpital Sud, Department of Gynecologic and Obstetric Surgery, Rennes, France.
Jean
J
LeVêque
Centre Hospitalier de Versailles-Hôpital Mignot, Department of Gynecologic and Obstetric Surgery, Le Chesnay, France.
Pierre
P
Panel
AP-HP, Hôpital Antoine Béclère, Department of Gynecologic and Obstetric Surgery, Clamart, France.
Hervé
H
Fernandez
Polyclinique du Tondu, Department of Gynecologic and Obstetric Surgery, Bordeaux, France.
Alain
A
Audebert
CHU d'Angers, Department of Gynecologic and Obstetric Surgery, Angers, France.
Philippe
P
Descamps
Centre Hospitaliers des quatre villes, Department of Gynecologic and Obstetric Surgery, Sèvres, France.
Nicolas
N
Castaing
CHU de Rouen, Department of Gynecologic and Obstetric Surgery, Rouen, France.
Horace
H
Roman
CHI Poissy Saint-Germain en Laye, Department of Gynecologic and Obstetric Surgery, Research Unit EA7285, University Versailles Saint-Quentin en Yvelines Poissy, France.
Arnaud
A
Fauconnier
AP-HP, Hôpital Armand Trousseau, Department of Gynecologic and Obstetric Surgery, Université Pierre et Marie Curie, Paris, France.
Jean Louis
JL
Benifla
D020341:Absorbable Implants; D005260:Female; D006801:Humans; D007813:Laparotomy / Q000379:methods*; D007889:Leiomyoma / Q000601:surgery; D008567:Membranes, Artificial; D011183:Postoperative Complications / Q000517:prevention & control*; D024162:Second-Look Surgery; D016037:Single-Blind Method; D000267:Tissue Adhesions / Q000517:prevention & control*; D063186:Uterine Myomectomy / Q000379:methods*; D014594:Uterine Neoplasms / Q000601:surgery
D008567:Membranes, Artificial
Laparotomy; Leiomyoma; Tissue adhesions; Uterine myomectomy