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

Rennes University Hospital

Status: Completed

Conditions: Spina Bifida

Treatments: Device: Retrograde Colonic Irrigation; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02361450

2013-A01520-45

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Retrograde Colonic Irrigation with usual care

Experimental group

Description:

In the experimental group, retrograde colonic irrigation sessions will be scheduled in addition to conventional treatment according to a progressive volume program.

Treatment:

Other: Usual Care

Device: Retrograde Colonic Irrigation

Usual Care

Active Comparator group

Description:

In the comparator group, patients will receive conventional care, according to each clinical center habits.

Treatment:

Other: Usual Care