The Efficacy and Safety of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions After Laparoscopic Gynecological Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 7
- 主要终点
- The adhesion incidence under moderate/severe category
研究概览
简要总结
The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery
详细描述
Postsurgical adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of the new crosslinked hyaluronan hydrogel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing laparoscopic surgeries. Subjects were scheduled to return at 9 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postsurgical adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring system.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18-45 years.
- •Been scheduled for removal of myomas, ovary cysts, endometriotic cysts or adhesions.
- •Been willing to comply with all aspects of the treatment and evaluation schedule.
- •Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 9 weeks following the primary surgery.
- •Provided voluntary written informed consent.
排除标准
- •Acute or severe infection.
- •Autoimmune diseases such as diabetes etc.
- •Abnormal liver/renal and cardiovascular function
- •Abnormal blood coagulation
- •Medical histories of peripheral vascular disease, alcohol or drug abuse, and mental illness.
- •Known or suspected intolerance or hypersensitivity to hyaluronan or its derivatives.
- •Concurrent use of systemic antiinflammatory drugs.
- •Clinical evidence of cancer.
- •Use of anticoagulant, fibrin glue, other thrombogenic agents, or any other anti-adhesion agent during the procedure.
- •Concurrent peritoneal grafting or tubal implantation.
结局指标
主要结局
The adhesion incidence under moderate/severe category
时间窗: 9 weeks following primary laparoscopic gynecological surgery
The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.
次要结局
- The adhesion incidence under moderate/severe category(9 weeks following primary laparoscopic gynecological surgery)
- Adverse events(Up to 9 weeks)
- modified American Fertility Society (mAFS) score(9 weeks following primary laparoscopic gynecological surgery)
- Adhesion extent(9 weeks following primary laparoscopic gynecological surgery)
- Adhesion severity(9 weeks following primary laparoscopic gynecological surgery)