An expanded polytetrafluoroethylene barrier (Gore-Tex Surgical Membrane) reduces post-myomectomy adhesion formation. The Myomectomy Adhesion Multicenter Study Group

Myomectomy Adhesion Multicenter Study Group

doi:10.1016/s0015-0282(16)57414-7

Reproductive Surgery · Adhesion Prevention

An expanded polytetrafluoroethylene barrier (Gore-Tex Surgical Membrane) reduces post-myomectomy adhesion formation. The Myomectomy Adhesion Multicenter Study Group

Myomectomy Adhesion Multicenter Study Group

Published March 1995 Fertility and Sterility, 63(3), 491-493

DOI 10.1016/s0015-0282(16)57414-7 PMID 7851575

Read our synopsis

RRM Academy Synopsis

Gore-Tex barrier reduced adhesions on myomectomy incisions

The barrier left about 6 out of 10 covered incisions free of adhesions, against about 1 out of 10 uncovered. The trial was randomized and included 27 women having myomectomy (fibroid removal). Each woman had one incision covered and one left bare. A second laparoscopy checked both 2 to 6 weeks later.

Key Findings

Adhesion-free sites: 15 of 27 covered incisions (55.6%) against 2 of 27 uncovered incisions (7.4%) (P < 0.0005).
Mean adhesion score on the 0 to 11 scoring system: 1.88 ± 0.46 (SEM) at covered sites and 7.55 ± 0.57 at uncovered sites (P < 0.0001).
After adhesions were lysed, the adhesion defect on the uterine surface averaged 1.3 ± 0.6 cm2 at covered sites and 7.3 ± 1.9 cm2 at uncovered sites (P < 0.0001).
The few adhesions at covered sites sat mainly along the barrier's edge. Removed membranes showed no tissue attachment, and no complications occurred from the myomectomy or second-look laparoscopy.

Interpretation

Each woman served as her own comparison, with two incisions randomly assigned to the barrier or to no cover. All had open myomectomy (laparotomy) with two incisions about 2 cm apart, on the fundus and posterior wall. Women needing one incision or an anterior-wall incision were excluded. The trial enrolled 28 women and analyzed 27 after one withdrew consent. The membrane's maker, W. L. Gore & Associates, funded it. Scorers checked adhesions once, at second laparoscopy. The paper reports no pregnancy, pain, or bowel outcomes. It does not say whether scorers knew which site was covered. The authors say a larger series must show whether adhesions form after removal.

RRM Context

The authors' working principle is that surgically injured tissue heals without adhesions when the surfaces stay mechanically apart and the barrier does not react with tissue. They note that adhesions near the ovaries and tubes may impair fertility. Restorative reproductive medicine treats adhesion prevention as part of protecting pelvic function. The 1995 trial tested one barrier on uterine incisions after fibroid removal. The paper reports no fertility results and did not study endometriosis surgery.

Our editorial summary of this paper, not the article's abstract.

Abstract

Objective

To evaluate the effects of the expanded polytetrafluoroethylene barrier (PTFE), Gore-Tex Surgical Membrane, in reducing postmyomectomy adhesion formation.

Design

Multicenter randomized clinical trial.

Interventions

Twenty-seven women having myomectomy with at least two incisions on the uterine fundus and posterior uterine wall of similar length were enrolled in the study. At laparotomy, the two incision sites were randomly assigned to be covered with PTFE or were left uncovered. A second-look laparoscopy to evaluate adhesion formation and to lyse adhesions was done from 2 to 6 weeks after the myomectomy. Adhesions were scored using a 0- to 11-point scoring system.

Results

At laparoscopy, 15 of 27 incisions covered with PTFE (55.6%) and only 2 of 27 uncovered sites (7.4%) were completely free of adhesions. The mean adhesion score at the PTFE sites was significantly lower (1.88 +/- 0.46; SEM) than at the control sites (7.55 +/- 0.57).

Conclusion

The PTFE barrier is effective in reducing postmyomectomy adhesion formation.

Topics

Reproductive Surgery Adhesion Prevention Barrier Agents

Related research

Adhesion Prevention · Barrier Agents

Expanded polytetrafluoroethylene (Gore-Tex Surgical Membrane) is superior to oxidized regenerated cellulose (Interceed TC7+) in preventing adhesions

Haney AF et al., 1995 Fertil Steril

To compare the impact of expanded polytetrafluoroethylene (PTFE; Gore-Tex Surgical Membrane; W. L. Gore & Associates, Inc., Flagstaff, AZ) and oxidized regenerated cellulose (Interceed TC7, Johnson & Johnson Medical, Inc., Arlington, TX) on the development of postsurgical adhesions. A multicenter, nonblinded, randomized clinical trial. University medical centers. Each barrier was allocated randomly to the left or right sidewall of every patient. Thirty-two women with bilateral pelvic sidewall adhesions undergoing reconstructive surgery and second-look laparoscopy. Adhesion score (on a 0- to 11-point scale), the area of adhesion (cm2), and the likelihood of no adhesions. The use of both barriers was associated with a lower adhesion score and area of adhesion postoperatively. However, those sidewalls covered with PTFE had a significantly lower adhesion score (0.97 +/- 0.30 versus 4.76 +/- 0.61 points, mean +/- SEM) and area of adhesion (0.95 +/- 0.35 versus 3.25 +/- 0.62 cm2). Overall, more sidewalls covered with PTFE had no adhesions (21 versus 7) and, when adhesions were present on the contralateral sidewall, the number of sidewalls covered with PTFE without adhesions was greater than those covered with oxidized regenerated cellulose (16 versus 2). Expanded polytetrafluoroethylene was associated with fewer postsurgical adhesions to the pelvic sidewall than oxidized regenerated cellulose.

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Laparoscopic implant of Gore-Tex surgical membrane

Crain J et al., 1995 J Am Assoc Gynecol Laparosc

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Eight patients with extensive adhesions and 10 undergoing myomectomy had Gore-Tex surgical membranes placed to prevent adhesion formation/reformation. At the time of second-look laparoscopy, the membranes were removed easily, and the extent of adhesion was minimal. Further studies are ongoing to validate these findings and to compare the Gore-Tex surgical membrane with antiadhesion agents.

Adhesion Prevention · Barrier Agents

Expanded-polytetrafluoroethylene but not oxidized regenerated cellulose prevents adhesion formation and reformation in a mouse uterine horn model of surgical injury

Haney AF et al., 1993 Fertil Steril

To evaluate the ability of the two currently available surgical barriers, oxidized regenerated cellulose and expanded-polytetrafluoroethylene (PTFE), to prevent postsurgical adhesions. Murine uterine horns were approximated in the midline and the contacting uterine surfaces injured by electrocautery, cutting, and scratching, with and without barriers interposed. Sham-operated and experimental animals had adhesions assessed visually and histologically 7 days postoperatively. In another group, adhesions were created and then lysed 7 days later with barriers interposed. Readhesion formation was assessed 14 days after lysis with the PTFE being removed 7 days after lysis. Research laboratory Adhesions occurred at 58.5% of the electrocautery sites without barriers, 100% of the readhesion sites with recautery for hemostasis, and 92% of the recautery sites without hemostasis. None of the sham-operated sites developed adhesions. When oxidized regenerated cellulose was interposed, adhesions were observed at 36% of uninjured uterine horn sites, 62% with single and 92% with double electrocautery injuries and 90% of the reformation sites. The PTFE did not cause adhesions in uninjured controls and completely prevented adhesion formation and reformation, regardless of the type of injury or whether hemostasis was achieved. A thin cellular membrane, continuous with the uterine serosa, enveloped the PTFE. Expanded-polytetrafluoroethylene, but not oxidized regenerated cellulose, prevents adhesion formation and reformation in this murine uterine horn model. Additionally, oxidized regenerated cellulose was adhesiogenic even without surgical injury.

Reproductive Surgery › Adhesion Prevention › Barrier Agents

PMID 7851575 7851575 DOI 10.1016/s0015-0282(16)57414-7 10.1016/s0015-0282(16)57414-7 Myomectomy Adhesion Multicenter Study Group et al. 1995, Myomectomy Adhesion Multicenter Study Group 1995

Cite this article

Myomectomy Adhesion Multicenter Study Group (1995). An expanded polytetrafluoroethylene barrier (Gore-Tex Surgical Membrane) reduces post-myomectomy adhesion formation. The Myomectomy Adhesion Multicenter Study Group. Fertility and Sterility, 63(3), 491-493. https://doi.org/10.1016/s0015-0282(16)57414-7

Keywords

Adolescent, Adult, Female, Humans, Laparoscopy, Leiomyoma/surgery, Polytetrafluoroethylene, Postoperative Complications/prevention & Control, Reoperation, Tissue Adhesions/prevention & Control, Uterine Diseases/prevention & Control, Uterine Neoplasms/surgery, Polytetrafluoroethylene