D A Johns1, R Ferland, R Dunn. 1. Texas Institute for Clinical Research, Fort Worth, Texas 76180, USA.
Abstract
STUDY OBJECTIVE: To assess the safety and effectiveness of SprayGel as a barrier to reduce the frequency of adhesion formation and reformation after ovarian surgery, and to determine the feasibility of the study design for a larger, multicenter pivotal trial. DESIGN: Prospective, randomized, internally controlled trial (Canadian Task Force classification I). SETTING:Two metropolitan, academic-affiliated, nonprofit hospitals. PATIENTS: Fourteen women. INTERVENTION: Bilateral adnexal surgery. MEASUREMENTS AND MAIN RESULTS: On completion of surgery, one adnexa was randomized to receive optimal surgical treatment plus application of the adhesion barrier, and the contralateral one to receive optimal surgical treatment alone. Patients returned in 3 to 16 weeks for second-look laparoscopy. All initial and second-look procedures were videotaped and reviewed by a blinded surgeon reviewer, and assessed for frequency, extent, and severity of adhesions. The frequency and extent of adhesion formation at second-look laparoscopy were statistically reduced on treatment sides compared with control sides (71% reduction in frequency, p = 0.0488; 69% reduction in extent, p = 0.0494). Adhesion severity score was reduced by 43% on the treatment side. SprayGel was associated with no adverse effects and was applied successfully in all patients. CONCLUSION: This material shows great promise in preventing postoperative adhesion formation in a population of patients greatly in need of such an adjunct. These findings warrant a larger, pivotal, multicenter study to evaluate SprayGel further.
RCT Entities:
STUDY OBJECTIVE: To assess the safety and effectiveness of SprayGel as a barrier to reduce the frequency of adhesion formation and reformation after ovarian surgery, and to determine the feasibility of the study design for a larger, multicenter pivotal trial. DESIGN: Prospective, randomized, internally controlled trial (Canadian Task Force classification I). SETTING: Two metropolitan, academic-affiliated, nonprofit hospitals. PATIENTS: Fourteen women. INTERVENTION: Bilateral adnexal surgery. MEASUREMENTS AND MAIN RESULTS: On completion of surgery, one adnexa was randomized to receive optimal surgical treatment plus application of the adhesion barrier, and the contralateral one to receive optimal surgical treatment alone. Patients returned in 3 to 16 weeks for second-look laparoscopy. All initial and second-look procedures were videotaped and reviewed by a blinded surgeon reviewer, and assessed for frequency, extent, and severity of adhesions. The frequency and extent of adhesion formation at second-look laparoscopy were statistically reduced on treatment sides compared with control sides (71% reduction in frequency, p = 0.0488; 69% reduction in extent, p = 0.0494). Adhesion severity score was reduced by 43% on the treatment side. SprayGel was associated with no adverse effects and was applied successfully in all patients. CONCLUSION: This material shows great promise in preventing postoperative adhesion formation in a population of patients greatly in need of such an adjunct. These findings warrant a larger, pivotal, multicenter study to evaluate SprayGel further.
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