Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 12
- 主要终点
- Neurogenic Bowel Dysfunction (NBD) score
研究概览
简要总结
Spina Bifida is a developmental congenital disorder caused by the incomplete closing of the embryonic neural tube, leading to serious malformations of the nervous system. Caudal neuropore malformations almost always lead to sensory-motor deficits (including complete paraplegia) with orthopedic deformations, pressure sores, and pelvic/perineal neurological dysfunctions (affecting the bladder-sphincter, anorectal, and genital sphere).
The purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only.
详细描述
Sphincter dysfunctions impair the quality of life and patients' self-esteem. However, defecation disorders are important issues the Spina Bifida National Reference Center has to deal with. Indeed, more than half of patients are concerned. These disorders are mainly due to fecal stasis. Treatments include laxatives and hygiene recommendations. Colonic irrigation can also be useful, especially to achieve colonic vacuity and improve continence. The use of intra-rectal balloon inflation probes and the control of instillation flow improved retrograde colonic irrigation efficacy. Nevertheless, this technique is currently not evaluated in young adults suffering from Spina Bifida functional digestive sequelae, who are mainly concerned by Malone enema.
The purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aging at least 15 years old with Spina Bifida neurological pelvi-perineal sequelae, objected by neurologic exam , functional urinary and/or anorectal and/or neurophysiological data,
- •Patients with NBD score above 9,
- •Written and informed consent (Minor children may be included with the consent of the two parents).
排除标准
- •Patients with psychiatric disorders, cognitive or intellectual disabilities compromising the assessment of primary outcome measure,
- •Patients using currently irrigation colonic technique,
- •Patients with functional colostomy, known anal or colorectal stenosis, colorectal cancer, acute or chronic inflammatory disease, recent anal or colorectal surgery for less than 3 months, polyp removal for less than 4 weeks, ischemic colitis.
- •Patients with urinary trophic or orthopedic disease with planned surgery during inclusion or follow-up periods,
- •Patients with progressive anal disease (suppuration, hemorrhoid or rectal prolapse)
- •Patient with a hard follow-up ( judged by the investigator)
- •Person involved in another clinical trial
- •Pregnant women
- •Person with a measure of legal protection (guardianship)
结局指标
主要结局
Neurogenic Bowel Dysfunction (NBD) score
时间窗: Ten weeks after inclusion
次要结局
- Quality of life(Twenty-four weeks after inclusion)
- Functional digestive score (NBD)(Twenty-four weeks after inclusion)
- Self esteem (Rosenberg scale)(Ten weeks after inclusion)
- Cumulative time spent using restrooms(Twenty-four weeks after inclusion)
- Stools consistency(Twenty-four weeks after inclusion)
- Number of incontinence guards used(Twenty-four weeks after inclusion)
- Questionnaire data of incontinence and constipation (Cleveland scores)(Twenty-four weeks after inclusion)
- Number of accidents of incontinence(Twenty-four weeks after inclusion)
- Type of incontinence guards used(Twenty-four weeks after inclusion)
- Number of stools(Twenty-four weeks after inclusion)
- Symptoms experienced during defecation(Twenty-four weeks after inclusion)
- Frequency of digital help during defecation(Twenty-four weeks after inclusion)