FOAM: Functional Outcome After Ventral Mesh Rectopexy, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Sexual function
研究概览
简要总结
Rectal prolapse is a protrusion of rectal wall through the anus. A surgical technique called Ventral mesh rectopexy has become a standard procedure for this condition in many centers.
The goal of this trial is to investigate functional outcome, recurrence rates and complications after ventral mesh rectopexy. The main question it aims to answer is:
- Do bowel function, quality of life and sexual function improve after Ventral mesh rectopexy?
Participants will:
- be asked to fill in questionaires before surgery, 3-6 months after surgery and 12 months after surgery.
- be examined by a surgeon 3-6 months, 12 months and 3 years after surgery.
详细描述
Several different procedures have been described for surgical treatment of rectal prolapse and a consensus has not yet been reached. Over the past 20 years, the use of Ventral mesh rectopexy to treat external rectal prolapse has gained increasing worldwide acceptance. Ventral mesh rectopexy has become a standard procedure in many centers based on low recurrence rates, limited complications and good functional results but the use and type of mesh have been debated. Concerns have also been expressed regarding the choice of surgical technique, which differs between centers, and the lack of high-level evidence.
There are few prospective trials and the use of LVMR in a Swedish setting has not yet been evaluated. FOAM (Functional Outcome After ventral Mesh rectopexy) therefore aims to investigate bowel function, quality of life, sexual function, recurrence rates and complications after ventral mesh rectopexy.
A prospective cohort study on patients undergoing ventral mesh rectopexy for external rectal prolapse in Sweden will be conducted. Approximately 70 patients will be included at a maximum of 10 hospitals in Sweden.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •full-thickness rectal prolapse
- •the surgeon agrees that ventral mesh rectopexy is needed for the condition
- •capable of participating in follow-up visits and answering questionnaires
- •informed consent
排除标准
- •patient below 18 years of age
- •ongoing pregnancy
- •inability to understand the Swedish language
- •dementia or other cognitive disorder that unables informed consent
结局指标
主要结局
Sexual function
时间窗: Evaluated at baseline, 3-6 months and 12 months postoperatively
PROMIS Sexual function and satisfaction version 2.0. Selected domains: Interest in sexual activity (scale 2-10, 10=highest interest), sexual activity screener (scale yes/no) and satisfaction with sex life (scale 2-10, 10=highest satisfaction)
Quality of Life after surgery
时间窗: Evaluated at baseline, 3-6 months and 12 months postoperatively
Colorectal-Anal Impact Questionnaire (CRAIQ-7): scale 0-100, 100=worst outcome
Bowel function
时间窗: Evaluated at baseline, 3-6 months and 12 months postoperatively
Colo-rectal-anal Distress Inventory (CRADI-8): scale 0-100 (100=worst outcome)
次要结局
- Mortality(Within 30 days postoperatively)
- Postoperative complications(Within 30 days postoperatively)
- Length of stay(From day of operation to day of discharge from hospital, reported at follow-up 3-6 months postoperatively.)
- Long-term complications(Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively.)
- Recurrence rate(Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively. Clinical examination by surgeon will be performed to evaluate recurrence.)