The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- The incidence of postoperative adhesion at 3 months
研究概览
简要总结
The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.
详细描述
The study is a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who are premenopausal and scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy. Patients recruited are randomly divided into five groups, PROTAHERE, Hyalobarrier, Seprafilm, Interceed or no treatment when the inclusion criteria are met and the inform consents are obtained. They are followed for 24 months including visits at 14 days, 3, 6, 12, 18, 24 months post-operation for the safety and effectiveness evaluation. The primary endpoints are the incidence of adhesions at 3-month as well as the incidence of any adverse events during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who are premenopausal.
- •Patients who are scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy.
- •Patients who are 20 years old or older.
- •Patients who are able to understand the objectives, sign the informed consent form, and willing to comply with study procedures.
排除标准
- •Patients who are 65 years old or older.
- •Presence of uncontrolled diabetes, coagulative disorders, severe urinary system infection, or other severe diseases.
- •Presence of malignant tumor or diagnosed with cancer.
- •Any physical or psychological illness or symptom which is considered unsuitable to enroll by physicians.
- •Patients who are unwilling to comply with study procedures.
- •Patients who are known to have hypersensitivity to hyaluronic acid implants.
结局指标
主要结局
The incidence of postoperative adhesion at 3 months
时间窗: 3 months post-operation
Divide the number of patients with postoperative adhesion at 3 months in each group by the total number of patients enrolled.
次要结局
- The total score of America Fertility Society classifications of adhesions at all sites in each group at 3 months(3 months post-operation)
- The incidence of each adverse event from the baseline and during the study(14 days, 3, 6, 12, 18, 24 months)
- The residual status of anti-adhesion agents at 3 months(3 months post-operation)
- The change of CA125 value in each group during the study period(3, 6, 12, 18, 24 months)
- The change of medication or treatment related to adverse event(14 days, 3, 6, 12, 18, 24 months)
- The score of adhesion severity and extent at each sites at 3 months(3 months post-operation)
- The incidence of adverse events in each group from the baseline and during the study period(14 days, 3, 6, 12, 18, 24 months)
- The severity of adverse events(14 days, 3, 6, 12, 18, 24 months)
- The proportion of sites with adhesions at 3 months(3 months post-operation)
- The incidence of postoperative adhesion from the baseline and during the study period(14 days, 3, 6, 12, 18, 24 months)
- The change of the results of SF-36 questionnaire in each group from the baseline and during the study period(14 days, 3, 6, 12, 18, 24 months)
- Visual analog scale (VAS) score for pain change(14 days, 3, 6, 12, 18, 24 months)