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

J Minim Invasive Gynecol. Mar-Apr 2010;17(2):222-7. doi: 10.1016/j.jmig.2009.12.018.

Abstract

Study objective: To assess the laparoscopic handling and safety of D,L-polylactide-epsilon-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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Female
  • Follow-Up Studies
  • Glucans / administration & dosage
  • Glucose / administration & dosage
  • Humans
  • Icodextrin
  • Laparoscopy*
  • Leiomyoma / pathology
  • Leiomyoma / surgery*
  • Peritoneal Diseases / etiology
  • Peritoneal Diseases / pathology
  • Peritoneal Diseases / prevention & control*
  • Pilot Projects
  • Polyesters / administration & dosage*
  • Single-Blind Method
  • Suture Techniques*
  • Tissue Adhesions / etiology
  • Tissue Adhesions / pathology
  • Tissue Adhesions / prevention & control
  • Treatment Outcome
  • Uterine Neoplasms / pathology
  • Uterine Neoplasms / surgery*

Substances

  • Glucans
  • Polyesters
  • polylactide-epsilon-caprolactonetrimethylenecarbonate
  • Icodextrin
  • Glucose