Surgical Treatment of Internal Rectal Prolapse Associated With Obstructed Defecation: Transanal Prolassectomy Versus Laparoscopic Ventral Rectopexy. Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Evaluation of different outcomes in relief from ODS after surgery in both groups
研究概览
简要总结
The objective of the study will be to evaluate the clinical and functional outcome of patients with obstructed defecation sndrome (ODS) associated to internal rectal prolapse, treated with transanal prolassectomy (STARR) surgery compared to those treated with laparoscopic ventral rectopexy (LVR).
详细描述
This randomized controlled trial (single center, prospective, randomized controlled, parallel, and single-blind trial) is designed to compare the outcome of patients with ODS and rectal prolapse undergoing transanal prolapsectomy with mechanical stapler (STARR) versus laparoscopic ventral rectopexy (LVR), with the aim of evaluating the most appropriate surgical choice.
The study will be conducted at the Surgical Unit 2 of the University Hospital of Ferrara, Italy. Patients suffering from rectal prolapse and ODS that will refer to the colorectal and pelvic floor clinic of the University Hospital Ferrara, and eligible for surgery, will be evaluated consecutively after expressing consent to participate in the study by signing an informed consent.
The duration of the study for each patient will be expected to be 48 months with follow-up at 1, 3, 6, 12, 24, 36, and 48 months postoperatively.
Eligible patients will receive information about participating in the trial by their surgeon. Consecutive eligible patients will be randomly assigned to one of two groups with a 1:1 equal allocation ratio.
Patients eligible for the study will be randomized on a 1:1 basis to undergo transanal prolassectomy (Group 1: STARR) or laparoscopic ventral rectopexy with mesh placement (Group 2: LVR).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female gender,
- •the presence of rectorectal or rectoanal intussusception as main cause of ODS, confirmed by defecography,
- •type of operation performed (STARR or LVR),
- •ODS score > 14 [17]
- •PACQoL >32 [18]
- •ODS symptoms for at least 12 months prior to enrollment
- •Failure of at least 6 months of medical therapy
排除标准
- •male gender,
- •severe fecal incontinence (CCS score>6, Maximum Resting Pressure at rectal manometry < 50 mmHg),
- •combined procedures
- •previous surgery on rectum or anus for cancer or rectal prolapse, inflammatory bowel disease, other type of surgery to relieve ODS
- •pregnancy,
- •anismus or dissinergic defecation
- •full-thickness prolapse
- •stress urinary incontinence associated
- •histerocele or cystocele associated (since we usually correct both defects in the same surgical procedure)
- •prior pelvic radiotherapy
- •slow transit constipation defined as ≤ 2 bowel movements per week,
- •any psychiatric diseases.
结局指标
主要结局
Evaluation of different outcomes in relief from ODS after surgery in both groups
时间窗: 4 years
In order to evaluate the short- and long-term efficacy of STARR procedure compared to LVR, the percentage of changes in total ODS, PAC-QoL, PFDI, PFQI, Wexner Constipation, the Cleveland Clinic Fecal Incontinence (CCFI) scores between baseline and 6, 12, 24, 36, and 48 months after surgery, were adopted as primary outcome.
次要结局
- long-term postoperative complications(4 years)
- recurrence or persistence of ODS (Obstructed defecation syndrome)(4 years)
- short-term postoperative complications (within 30 days after surgery)(4 years)
- recurrence or persistence of rectal prolapse(4 years)
- patient satisfaction in terms of pain(4 years)
研究者
Simona Ascanelli
Principal Investigator
University Hospital of Ferrara