Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations, a Prospective Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- anatomical success of the operations
研究概览
简要总结
The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.
详细描述
The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.Computerized random number table will be used as randomization method. Patients who agree to participate in the study and fulfill the inclusion criteria will be evaluated on the effects of prolapse on quality of life and sexual function before and after the surgical procedures and their complaints and satisfaction will be questioned. Surgical success and complications will be evaluated. Changes in the level of prolapse will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients between the ages of 18-60
- •No previous prolapse surgery
- •Not having a chronic disease
- •Having stage 3-4 prolapse
排除标准
- •Outside the age range of 18-60 years
- •Previous prolapse surgery
- •Having early stage (1-2) prolapse
- •History of chronic disease
结局指标
主要结局
anatomical success of the operations
时间窗: changes at 1 and 3 months after surgery
comparition of preoperative and postoperative pelvic organ prolapse quantification system (POP-Q) measurements of the patients
次要结局
- evaluation of the sexual functions of the patients(changes at 1 and 3 months after surgery)
研究者
Gamze Nur Cimilli Şenocak
associate professor
Ataturk University