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RESEARCH PRODUCT

A pilot study of laparoscopic adhesion prophylaxis after myomectomy with a copolymer designed for endoscopic application.

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Abstract Study Objective To assess the laparoscopic handling and safety of D,L-polylactide-e-caprolactone-trimethylene carbonate (PCT) copolymer after myomectomy and compare it with icodextrin. In contrast to previously developed solid barriers, the material has rationally designed properties that are advantageous for convenient laparoscopic application. Design A randomized, single-blinded clinical study (Canadian Task Force Classification I). Setting Single-center study in a German University Hospital. Patients Thirty patients who underwent laparoscopic myomectomy were enrolled. Interventions After laparoscopic myomectomy and subsequent reconstruction of the uterus with interrupted sutures, adhesion prophylaxis with either site-specific PCT copolymer or icodextrin occurred as per randomization. Measurements and Main Results Except in 1 case, complete coverage of the uterine wound was achieved with PCT copolymer, and the mean time taken for application was 6.7 minutes. Mean application time for icodextrin was 1.1 minute. After introduction into the abdomen, PCT copolymer changed into a flexible state that adapted very well to the operative anatomy. The patients were followed up according to the study protocol for 3 months. There were no unforeseen adverse events, possible adhesion-related complications, or nonspecific complications in either study arm. There was no significant difference in pelvic pain scores between PCT copolymer and icodextrin groups 3 months after surgery. Conclusion In this pilot study, there were no adverse events, and the rationally designed material properties are favorable for laparoscopic application. No differences in postoperative pelvic pain were ascertained between PCT copolymer and icodextrin. Therefore a human phase II trial including second-look laparoscopy should be conducted to further evaluate this new solid adhesion barrier PCT copolymer.