Adhesion Prevention · Barrier Agents
Myomectomy Adhesion Multicenter Study Group, 1995 · Fertil Steril
To evaluate the effects of the expanded polytetrafluoroethylene barrier (PTFE), Gore-Tex Surgical Membrane, in reducing postmyomectomy adhesion formation. Multicenter randomized clinical trial. 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. 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). The PTFE barrier is effective in reducing postmyomectomy adhesion formation.
Adhesion Prevention · Barrier Agents
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.
Adhesion Prevention · Barrier Agents
Crain J et al., 1995 · J Am Assoc Gynecol Laparosc
One of the major postoperative complications of reproductive surgery is the formation of adhesions. 1, 2 Over the past several decades a number of methods have been explored to solve this problem, g, 4 Recently there has been renewed interest in covering the damaged peritoneal surface with an absorbable or nonabsorbable barrier as a means of preventing adhesions after fertility-enhancing surgery. Currently, two barriers are commercially available for clinical use: Interceed Absorbable Adhesion Barrier (Ethicon, Somerville, NJ), which is composed of oxidized regenerated cellulose, and the Gore-Tex Surgical Membrane (W. L. Gore & Associates, Inc., Flagstaff, AZ), constructed of expanded polytetrafluoroethylene (e-PTFE). Interceed has been investigated both experimentally and clinically and has proved effective in some circumstances. 5,6 Studies also report on the laparoscopic application of Interceed in fertility-enhancement procedures.7, 8 Recent reports, however, have questioned the product's degree of effectiveness and raised concern about possible residual effects it may have on peritoneal tissue? 11 Gore-Tex Surgical Membrane has been indicated for use in peritoneal reconstruction since 1983, and experimental and clinical reports describe its effectiveness in preventing adhesion formation. 12-14
Interceed is an absorbable material that is phagocytized by macrophages within 1 month. Gore-Tex Surgical Membrane is nonabsorbable and is intended to be a permanent implant. Since all published reports on the clinical application of the Gore-Tex membrane discuss implantation by laparotomy, ~g, 14 the ease of use of this product in laparoscopic surgery is of particular interest. Moreover, because of its permanence, its long-term safety and effectiveness merit examination. A prospective, multicenter clinical study was undertaken to evaluate the ease of using Gore-Tex Surgical Membrane laparoscopically.
Adhesion Prevention · Barrier Agents
Wiseman D et al., 2000 · Cochrane Database Syst Rev
Pelvic adhesions can be the result of inflamation, endometriosis or surgical trauma. Prevention of postoperative adhesions (either new or reoccurance) has been postulated by using barriers to prevent two surfaces being in contact. When pelvic surgery is being undertaken strategies to reduce pelvic adhesions occurring may be undertaken and these include barrier agents which are placed between the pelvic structures. Two synthetic barriers with differential characteristics are commercially available: oxidised regenerated cellulose (Interceed) and polytetrafluoroethylene (PTFC) (GoreTex). The objective of this review was to assess the effect of mechanical barriers (materials interposed between pelvic structures to prevent adherence of serosal surfaces) used during pelvic surgery in women of reproductive age on pregnancy rates, pelvic pain, or postoperative adhesion reformation.
Search Strategy: The Cochrane Menstrual Disorders and Subfertility Group specialised register of controlled clinical trials was undertaken. In addition, companies were contacted for unpublished trials.
Selection Criteria: Randomised controlled trials or controlled clinical trials of barriers versus no treatment or other barriers in women undergoing fertility preserving pelvic surgery. Reviewers assessed eligibility and trial quality. MAIN 15 randomised controlled trials were included. Five trials randomised patients while the remainder randomised pelvic organs. Laparoscopy was the primary surgical technique in six trials while the remaining trials were laparotomy. Indications for surgery included myomectomy (five trials), ovarian surgery (four trials), pelvic adhesions (six trials), endometriosis (two trials) and mixed (one trial). Thirteen trials assessed Interceed versus no treatment, two assessed Interceed versus Gore-Tex, one trial assessed Gore-Tex versus no treatment, and one trial assessed Seprafilm versus no treatment. No study reported pregnancy or reduction in pain as an outcome. The use of Interceed in women was associated with reduced incidence of pelvic adhesion formation, both new formation and re-formation following laparoscopic surgery and after laparotomy. Gore-Tex was more effective than no barrier or Interceed in preventing adhesion formation. There was limited evidence that Seprafilm was effective in preventing adhesion formation in women following myomectomy. REVIEWER'S The absorbable adhesion barrier Interceed reduces the incidence of adhesion formation, both new formation and re-formation, at laparoscopy and laparotomy, but there are insufficient data to support its use to improve pregnancy rates. Gore-Tex may be superior to Interceed in preventing adhesion formation but its usefulness is limited by the need for suturing and later removal. There was no evidence of effectiveness of Seprafilm in preventing adhesion formation.