Gynecologic use of Sepraspray Adhesion Barrier for reduction of adhesion development after laparoscopic myomectomy: a pilot study.

OBJECTIVE: To assess the safety and efficacy of Sepraspray Adhesion Barrier (a modified hyaluronic acid and carboxymethylcellulose powder) after laparoscopic surgery, in view of both the high efficacy of Seprafilm Adhesion Barrier in reducing postoperative adhesions after open surgical procedures and the difficulty with laparoscopic delivery.
DESIGN: Multicenter, randomized, reviewer-blinded trial.
SETTING: Reproductive endocrinology and infertility clinics. PATIENT(S): Women undergoing laparoscopic myomectomy for indications including infertility. INTERVENTION(S): Randomization to treatment with (n = 21) or without (n = 20) Sepraspray Adhesion Barrier. MAIN OUTCOME MEASURE(S): Postoperative adhesions development was assessed at early second-look laparoscopy. Adhesions were scored using the modified American Fertility Society scoring system. RESULT(S): Surgical procedure duration length was 99 versus 102 minutes in the control versus Sepraspray Adhesion Barrier groups, respectively, with the median number of fibroids removed being two in each group and corresponding fibroid weights of 134 ± 103 versus 113 ± 161 g, respectively. Adhesions scores increased in both the control and Sepraspray Adhesion Barrier groups, with larger although nonstatistically significant increases noted in control subjects when evaluating for the anterior uterus, the posterior uterus, and the entire uterus. CONCLUSION(S): Laparoscopic application of Sepraspray Adhesion Barrier after myomectomy in this pilot study was associated with a trend toward a reduction in postoperative adhesion development, as well as an encouraging safety profile. Further evaluation is warranted. CLINICAL TRIAL NUMBER: Sepraspray Adhesion Barrier #NCT00624930.

RCT Entities:   Population Interventions Outcomes