Reduction of postoperative adhesions after laparoscopic gynecological surgery with Oxiplex/AP Gel: A pilot study

Phil Young, Alan Johns, Claire Templeman, Craig Witz, Bobby Webster, Roger Ferland, Michael P. Diamond, Kathleen Block, Gere DiZerega

Research output: Contribution to journalArticle

54 Scopus citations

Abstract

Objective: To determine whether Oxiplex/AP Gel (FzioMed, San Luis Obispo, CA) was safe and preliminarily effective in reducing postsurgical adhesions after adnexal surgery by laparoscopy. Design: Prospective, multicenter, double-blind, randomized, U.S. Food and Drug Administration-monitored feasibility study. Setting: University and private clinics. Patient(s): Patients undergoing laparoscopic surgery with pelvic adhesions, tubal occlusion, endometriosis, and/or dermoids were randomized to receive Oxiplex/AP Gel or no further treatment after surgery. Intervention(s): A blinded, parallel-group design was conducted at six centers. Patients (aged 18-46 years) underwent laparoscopic surgery, with second-look surgery 6-10 weeks later. Surgeries were videotaped. Oxiplex/AP Gel was used to cover adnexa and adjacent tissue. Main Outcome Measure(s): Blinded reviews of videotapes were quantitated with the American Fertility Society adhesion score (AFS score). Result(s): In 18 treatment patients, surgery was performed on 29 adnexa. Application of Oxiplex/AP Gel required approximately 90 seconds. In 10 control patients, surgery was performed on 18 adnexa. The mean baseline AFS score for each group was 8.0. At second look, treated adnexa had the same score (8.1), whereas in control adnexa the score increased (from 8.0 to 11.6). Thirty-four percent of treated adnexa increased in adhesion score, in contrast to 67% of control adnexa. There were no device-related adverse events. Conclusion(s): In this pilot study, Oxiplex/AP Gel was safe, easy to use with laparoscopy, and produced a reduction in the increase of adnexal adhesion scores.

Original languageEnglish (US)
Pages (from-to)1450-1456
Number of pages7
JournalFertility and sterility
Volume84
Issue number5
DOIs
StatePublished - Nov 1 2005
Externally publishedYes

Keywords

  • Adhesions
  • Oxiplex/AP Gel
  • Surgery

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

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