Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Changes in the ODS score (ODS-S)
研究概览
简要总结
Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. The most used procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR). However, high-level prospective studies on treatment strategies for ODS currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients affected by obstructed defecation with a minimum ODS score of 10
- •External rectal prolapse or high-grade internal rectal prolapse
- •Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement
- •Have experienced ODS symptoms for at least 12 months prior to enrollment
- •Failure of at least 6 months of medical therapy
- •American Society of Anesthesiologists (ASA) score of no more than 3
排除标准
- •Slow transit constipation
- •Anismus resistant to conventional treatment
- •No demonstrable pelvic anatomical problem
- •Previous rectal or anal surgery
- •Recto-vaginal fistula
- •Pregnancy
- •Previous pelvic radiotherapy
- •Severe proctitis or significant rectal fibrosis
- •Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease
- •Perineal infection
- •High-grade endometriosis
- •Morbid obesity
- •A hostile abdomen
- •Psychological instability
研究组 & 干预措施
LVMR
Modified Laparoscopic Ventral Mesh Rectopexy
干预措施: Modified Laparoscopic Ventral Mesh Rectopexy (Procedure)
LVMR with STARR
Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
干预措施: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection (Procedure)
结局指标
主要结局
Changes in the ODS score (ODS-S)
时间窗: Baseline and 12 months after surgery
The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery.
次要结局
- Radiological outcome as assessed by defecography(Baseline and 12 months after surgery)
- Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL)(Baseline, 1, 3, 6, and 12 months after surgery)
- Changes in Cleveland Clinic Fecal Incontinence Score (CCFI)(Baseline, 1, 3, 6, and 12 months after surgery)
- Changes in Fecal Incontinence Quality of Life Scale (FIQoL)(Baseline, 1, 3, 6, and 12 months after surgery)
- Postoperative complications(0 to 12 months after surgery)
- Changes in Health-Related Quality of Life(Baseline, 1, 3, 6, and 12 months after surgery)
- Changes in the ODS score (ODS-S)(Baseline, 1, 3, 6, and 12 months after surgery)
研究者
Tao Fu
Chief of Department of Gastrointestinal Surgery II
Renmin Hospital of Wuhan University