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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-16

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spina Bifida

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Retrograde Colonic Irrigation with usual care

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

Group Type EXPERIMENTAL

Retrograde Colonic Irrigation

Intervention Type DEVICE

Usual Care

Intervention Type OTHER

Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Interventions

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Retrograde Colonic Irrigation

Intervention Type DEVICE

Usual Care

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No