腹腔镜下附件手术使用Oxiplex/AP凝胶减少术后粘连的初步研究

来源 :世界核心医学期刊文摘(妇产科学分册) | 被引量 : 0次 | 上传用户:ydaf0rx0
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Objective: To determine whether Oxiplex/AP Gel (FzioMed, San Luis Obispo, CA) was safe and preliminarily effective in reducing postsurgical adhesions after adnexal surgery by laparoscopy. Design: Prospective, multicenter, double-blind, randomized, U.S. Food and Drug Administration-monitored feasibility study. Setting: University and private clinics. Patient (s): Patients undergoing laparoscopic surgery with pelvic adhesions, tubal occlusion, endometriosis, and/or dermoids were randomized to receive Oxiplex/AP Gel or no further treatment after surgery. Intervention(s): A blinded, parallelgroup design was conducted at six centers. Patients (aged 18-46 years) underwent laparoscopic surgery, with secondlook surgery 6-10 weeks later. Surgeries were videotaped. Oxiplex/AP Gel was used to cover adnexa and adjacent tissue. Main Outcome Measure(s): Blinded reviews of videotapes were quantitated with the American Fertility Society adhesion score (AFS score). Result(s): In 18 treatment patients, surgery was performed on 29 adnexa. Application of Oxiplex/AP Gel required approximately 90 seconds. In 10 control patients, surgery was performed on 18 adnexa. The mean baseline AFS score for each group was 8.0. At second look, treated adnexa had the same score (8.1), whereas in control adnexa the score increased (from 8.0 to 11.6). Thirty-four percent of treated adnexa increased in adhesion score, in contrast to 67%of control adnexa. There were no device-related adverse events. Conclusion(s): In this pilot study, Oxiplex/AP Gel was safe, easy to use with laparoscopy, and produced a reduction in the increase of adnexal adhesion scores. Objective: To determine whether Oxiplex / AP Gel (FzioMed, San Luis Obispo, CA) was safe and preliminarily effective in reducing postsurgical adhesions after adnexal surgery by laparoscopy. Design: Prospective, multicenter, double-blind, randomized, US Food and Drug Administration Settings: University and private clinics. Patient (s): Patients undergoing laparoscopic surgery with pelvic adhesions, tubal occlusion, endometriosis, and / or dermoids were randomized to receive Oxiplex / AP Gel or no further treatment after surgery. Intervention Patients (aged 18-46 years) underwent laparoscopic surgery, with secondlook surgery 6-10 weeks later. Surgiies were videotaped. Oxiplex / AP Gel was used to cover adnexa and adjacent tissue. Main Outcome Measure (s): Blinded reviews of videotapes were quantitated with the American Fertility Society adhesion score (AFS score). Results (s): In 18 treatment patients, Surgery was performed on 29 adnexa. Application of Oxiplex / AP Gel required approximately 90 seconds. In 10 control patients, surgery was performed on 18 adnexa. The mean baseline AFS score for each group was 8.0. At second look, treated adnexa had the same score (8.1), while in control adnexa the score increased (from 8.0 to 11.6). Thirty-four percent of treated adnexa increased in adhesion score, in contrast to 67% of control adnexa. There were no device-related adverse events. Conclusion (s): In this pilot study, Oxiplex / AP Gel was safe, easy to use with laparoscopy, and produced a reduction in the increase of adnexal adhesion scores.
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