"Impact of Pelvic Floor Prehabilitation Using Biofeedback on the Severity of the Low Anterior Resection Syndrome in Patients Undergoing a Total Mesorectal Excision for Rectal Cancer"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Severity of Low Anterior Resection Syndrome Score (LARS score)
研究概览
简要总结
There is currently no specific treatment and only few measures to prevent the low anterior resection syndrome (LARS). The LARS often results in a severe alteration of quality of life. This study is designed to assess pelvic floor prehabilitation using biofeedback in the prevention of LARS following total mesorectal excision for cancer. The pelvic floor rehabilitation with biofeedback has already been tested postoperatively in patients suffering from LARS with heterogeneous results. However, this rehabilitation has never been evaluated in the prevention of LARS.
The prehabilitation is an innovative concept currently evaluated in the prevention of functional complications following orthopedic surgery and also prostate surgery. In high-risk abdominal surgery, cardiopulmonary prehabilitation offers satisfying results in terms of morbidity and mortality rates. This study will be the first to assess pelvic floor prehabilitation in the prevention of LARS.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years old
- •Total mesorectal excision with colorectal or coloanal anastomosis protected by an ileostomy or a colostomy for rectal cancer
- •Absence of anastomotic leakage or stenosis
- •Informed consent to participate in the study
- •Social security insurance affiliation
排除标准
- •History of anal incontinence and/or fecal urgency and/or chronic diarrhea requiring a specific treatment before rectal cancer management
- •Absence of ileostomy or colostomy
- •Anastomotic leakage
- •Sensorial or cognitive disorders impeding pelvic floor rehabilitation exercise
- •Pregnant women
- •Adults under guardianship
研究组 & 干预措施
No intervention
No pelvic floor prehabilitation will be proposed before stoma closure. The pelvic floor prehabilitation will be proposed to patients suffering from LARS
Prehabilitation
The systematic pelvic floor prehabilitation will start 4 weeks before stoma closure and will include 1 sessions per week before stoma closure and 1 sessions per week during 6 weeks following stoma closure. Complementary sessions are allowed if necessary.
干预措施: Pelvic floor prehabilitation (Procedure)
结局指标
主要结局
Severity of Low Anterior Resection Syndrome Score (LARS score)
时间窗: 6 months following stoma closure
questionnaire assessing the five symptoms of the Low Anterior Resection Syndrome : fecal incontinence, gas incontinence, stool frequency, stool clustering and urgency.Total score is reported (minimum score :0 / maximal score : 42)
次要结局
- Impact on quality of life evaluated by the dedicated and validated questionnaire(6 months following stoma closure)
- Severity of fecal incontinence symptoms evaluated by the dedicated and validated score : Jorge and Wexner score(6 months following stoma closure)
- Morbidity of pelvic floor prehabilitation using biofeedback.(6 months following stoma closure)
- Medico-economic impact of pelvic floor prehabilitation including the fecal incontinence related costs(6 months following stoma closure)