A Study of the Efficacy of Surgical Methods When Using Prolene Mesh for Pelvic Organ Prolapse in Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Postoperative rectal prolapse recurrence
研究概览
简要总结
The goal of this clinical trial was to compare two surgical techniques in female patients with full-thickness rectal prolapse. The main questions it aimed to answer were:
- Does modified rectosacrouteropexy with pelvic peritonization improve postoperative anatomical outcomes compared with conventional Wells rectopexy?
- Does modified rectosacrouteropexy with pelvic peritonization improve postoperative functional outcomes compared with conventional Wells rectopexy?
Researchers compared modified rectosacrouteropexy with pelvic peritonization with conventional Wells rectopexy to assess postoperative recurrence, complications, anorectal manometry, defecography findings, and pelvic floor symptom scores. Participants underwent one of the assigned surgical procedures and were followed after surgery with clinical assessment and pelvic floor function testing.
详细描述
This is a prospective randomized comparative study conducted at Azerbaijan Medical University. Female patients with full-thickness rectal prolapse are assigned to modified rectosacrouteropexy with pelvic peritonization or conventional Wells rectopexy. Participants are followed for postoperative anatomical and functional outcomes, including recurrence, complications, anorectal manometry findings, defecography findings, and pelvic floor symptom scores.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Not informed
入排标准
- 年龄范围
- 47 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with full-thickness rectal prolapse Patients scheduled for surgical treatment with modified rectosacrouteropexy with pelvic peritonization Ability to complete postoperative follow-up assessments
排除标准
- •Male patients Patients without full-thickness rectal prolapse Contraindication to surgery or anesthesia Severe uncontrolled medical condition that could interfere with participation or follow-up
研究组 & 干预措施
Arm Title: Modified rectosacrouteropexy
Participants undergo modified rectosacrouteropexy with pelvic peritonization for full-thickness rectal prolapse.
干预措施: Modified rectosacrouteropexy (Procedure)
Arm Title: Wells rectopexy
Participants undergo conventional Wells rectopexy for full-thickness rectal prolapse
干预措施: Wells rectopexy (Procedure)
结局指标
主要结局
Postoperative rectal prolapse recurrence
时间窗: Up to 24 months after surgery
Recurrence of full-thickness rectal prolapse after surgery, assessed during postoperative follow-up
次要结局
- Postoperative complications(Up to 24 months after surgery)
研究者
Mahira Amirova
Assoc.Prof
Azerbaijan Medical University