NCT01899209Unknown不适用
Obstructed Defecation Caused by Rectal Intussusception and Rectocele:STARR Versus Laparoscopic Ventral Rectopexy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Functional result
研究概览
简要总结
Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures has been introduced to treat patients affected by this disease. The most used are STARR and ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients affected by Obstructed Defecation with ODS score >11
- •Symptomatic rectal Intussusception and/or defecographic finding of rectocele>2 cm
- •Failure of at least 6 months of medical therapy
- •Exclusion of neoplasm by rectosigmoidoscopy/colonoscopy
排除标准
- •Patients affected by complete rectal prolapse
- •Patients affected by slow transit constipation
- •Patients affected by anismus
- •Patients affected by pelvic organ prolapse
- •Patients with previous rectal or anal surgery
结局指标
主要结局
Functional result
时间窗: 12 months
comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery
次要结局
- Anatomical result(12 months)
研究者
Dajana Cuicchi
Dr Dajana Cuicchi
IRCCS Azienda Ospedaliero-Universitaria di Bologna
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Surgical Treatment for ODS With Rectal Prolapse Surgical Treatment for Rectal ProlapseConstipation by Outlet ObstructionNCT03487640Third Military Medical University16
招募中
不适用
Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation SyndromeObstructive Defecation SyndromeRectal ProlapseChronic ConstipationNCT03060330Renmin Hospital of Wuhan University126
已完成
不适用
Obstructed Defaecation: Proctography Versus Ultrasound in Symptomatic PatientsObstructed Defaecation SyndromeNCT02239302Croydon University Hospital131
招募中
不适用
Utilization of Transanal Endoscopy in the Treatment of Anastomotic StenosisAnastomotic StenosisNCT06036862Sun Yat-sen University50
已完成
不适用
Long Term Results of STARR With Contour TranstarRectal ProlapseRectoceleIntussusception of RectumNCT02971332University of Roma La Sapienza113