A Randomized, Multi-Center, Clinical Trial to Assess the Efficacy and Safety of Alginate Carboxymethylcellulose Hyaluronic Acid Compared to Carboxymethylcellulose Hyaluronic Acid to Prevent Postoperative Intrauterine Adhesion

초록

Study Objective: To estimate the efficacy of alginate carboxymethylcellulose hyaluronic acid (ACH) gel to prevent intrauterine adhesions after hysteroscopic surgery in comparison with carboxymethylcellulose hyaluronic acid (CH) gel, which is known as an effective adhesion inhibitor. Design: Randomized, multicenter, single-blind, clinical trial (Canadian Task Force classification I). Setting: Tertiary university hospital. Patients: One hundred eighty-seven patients with a surgically treatable intrauterine lesion (myomas, polyps, septa, intrauterine adhesion, dysfunctional uterine bleeding). Interventions: Patients were randomized to 2 groups: hysteroscopic surgery plus intrauterine application of ACH or CH. Measurements and Results: The rate of adhesion formation and the adhesion severity score with type and extent were calculated 4 weeks after surgery. The ACH group had results that were comparable to the CH group in terms of the development of intrauterine adhesions at 4 weeks follow-up. The adhesion severities were not different between the 2 groups. In a subgroup without baseline intrauterine adhesion, the ACH group showed a lower intrauterine adhesion rate than the CH group (p = .016). Conclusions: ACH had a comparable efficacy to CH in terms of the adhesion rate and severity. In the case of no baseline intrauterine adhesion, intrauterine application of ACH after hysteroscopic surgery had a lower rate of intrauterine adhesion than application of CH. Journal of Minimally Invasive Gynecology (2012) 19, 731-736 (C) 2012 AAGL. All rights reserved.

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