Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial

Rennes University Hospital34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * 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)

Locations (6)

CHRU de Lille

Lille, France

CHU de Nantes

Nantes, France

CMRRF de Kerpape

Ploemeur, France

Rennes University Hospital

Rennes, France

CHU de Rouen

Rouen, France

CHRU de Nancy-Brabois

Vandœuvre-lès-Nancy, France