Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH™
| Autor: | Alain Audebert, Hervé Fernandez, Emile Daraï, Jean Lévêque, Pierre Panel, Michel Canis, Patrick Madelenat, Philippe Descamps, Arnaud Fauconnier, Horace Roman, Jean Louis Benifla, Nicolas Castaing, G. Triopon |
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| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Adhesion (medicine) Tissue Adhesions law.invention Postoperative Complications Randomized controlled trial law Laparotomy Absorbable Implants Uterine Myomectomy medicine Humans Single-Blind Method Laparoscopy Leiomyoma medicine.diagnostic_test business.industry Obstetrics and Gynecology Membranes Artificial Pelvic cavity medicine.disease Uterine myomectomy Surgery Clinical trial medicine.anatomical_structure Reproductive Medicine Second-Look Surgery Uterine Neoplasms Female business |
| Zdroj: | European Journal of Obstetrics & Gynecology and Reproductive Biology. 178:42-47 |
| ISSN: | 0301-2115 |
| Popis: | 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 >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™ significantly reduced adhesion incidence and severity after laparotomic myomectomy. Clinical trial registration NCT01388907 ( www.clinicaltrials.gov ). |
| Databáze: | OpenAIRE |
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