Reproductive Surgery · Adhesion Prevention
RRM Academy Synopsis
Seprafilm barrier reduced uterine adhesions after myomectomy
Seprafilm membrane reduced uterine adhesions after myomectomy in a randomized trial of 127 women. Women given Seprafilm averaged 4.98 adhesion sites on the uterus, and women given no treatment averaged 7.88. The authors found no adverse events judged related to the device.
Key Findings
- Sites adherent to the uterine surface averaged 4.98 ± 0.52 [mean ± SEM] with Seprafilm and 7.88 ± 0.48 with no treatment, a significant difference.
- Adhesion severity scores were 1.94 ± 0.14 with Seprafilm versus 2.43 ± 0.10 with no treatment. Extent scores were 1.23 ± 0.12 versus 1.68 ± 0.10.
- Mean adhesion area was 13.2 ± 1.67 cm2 with Seprafilm and 18.7 ± 1.66 cm2 with no treatment, a 29% lesser area of uterine involvement.
- Among women with an anterior incision, 39% of treated and 6% of untreated women had no anterior adhesions (P < 0.0001). Posteriorly, 13% and 8% were adhesion free, a nonsignificant trend.
- Women with at least one adnexa clear of adhesions to the uterus numbered 48% with Seprafilm and 31% with no treatment (P < 0.05).
Interpretation
Women were randomly assigned by sealed envelope to Seprafilm or no treatment. One surgeon who did not know the assignment scored videotapes of second-look laparoscopies. The outcome was adhesions at 13 pelvic sites. The trial measured no pregnancy or pain outcomes, which the authors judged unreasonable for its scope. The manufacturer sponsored the trial, and the first author is a consultant to it and received research support from it. The analysis covered 117 of the 127 women and used one-sided tests. Every participant had a posterior uterine incision of at least 1 cm, so the results apply to that surgical setting.
RRM Context
Restorative reproductive medicine seeks to preserve how the tubes and ovaries work. The paper reports that adhesions form in 55% to 100% of patients after gynecologic surgery and often result in infertility. A study the paper cites found adhesions to the adnexa in 94% of women with a posterior myomectomy incision. The trial tests one barrier product against that problem.
Abstract
Objective
To assess the safety and efficacy of Seprafilm (HAL-F), Bioresorbable Membrane, (Genzyme Corporation, Cambridge, MA) in reducing the incidence, severity, extent, and area of uterine adhesions after myomectomy.
Design
Prospective, randomized, blinded, multicenter study. Adhesion reduction was assessed by an independent, blinded, gynecologic surgeon who reviewed videotapes of each patient's second-look laparoscopy.
Setting
Nineteen institutions across the United States.
Patients
One hundred twenty-seven women undergoing uterine myomectomy with at least one posterior uterine incision > or = 1 cm in length.
Interventions
Patients were randomized to treatment with Seprafilm or to no treatment at the completion of the myomectomy.
Main Outcome Measures
The incidence, severity, extent, and area of uterine adhesions at second-look laparoscopy.
Results
The incidence, measured as the mean number of sites adherent to the uterine surface, was significantly less in treated patients (4.98 +/- 0.52 [mean +/- SEM] sites) than in no treatment patients (7.88 +/- 0.48 sites) as were the mean uterine adhesion severity scores (1.94 +/- 0.14 versus 2.43 +/- 0.10; treatment versus no treatment, respectively), mean extent scores (1.23 +/- 0.12 versus 1.68 +/- 0.10), and mean area of adhesions (13.2 +/- 1.67 versus 18.7 +/- 1.66 cm2). No adverse events occurred that were judged to be related to the use of Seprafilm.
Conclusions
In this multicenter study, treatment of patients after myomectomy with Seprafilm significantly reduced the incidence, severity, extent, and area of postoperative uterine adhesions. Additionally, Seprafilm treatment was not associated with an increase in postoperative complications.
Topics
Keywords
Adult, Female, Humans, Incidence, Membranes, Artificial, Postoperative Complications/prevention & Control, Prospective Studies, Reoperation, Single-Blind Method, Tissue Adhesions/epidemiology/etiology/prevention & Control, Uterine Diseases/epidemiology/etiology/prevention & Control, Membranes, Artificial