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

NCT02361450 | Completed

• 1 other identifier: 2013-A01520-45
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Spina Bifida

Keywords

Faecal incontinence; Spina Bifida; Enema; Constipation; Myelomeningocele; Human

Outcome Measures

Primary Outcomes (1)

• Neurogenic Bowel Dysfunction (NBD) score

  Ten weeks after inclusion

Secondary Outcomes (22)

• Questionnaire data of incontinence and constipation (Cleveland scores)

  Ten weeks after inclusion

• Questionnaire data of incontinence and constipation (Cleveland scores)

  Twenty-four weeks after inclusion

• Quality of life

  Ten weeks after inclusion

• Quality of life

  Twenty-four weeks after inclusion

• Self esteem (Rosenberg scale)

  Ten weeks after inclusion

Study Arms (2)

Retrograde Colonic Irrigation with usual care

EXPERIMENTAL

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

Device: Retrograde Colonic Irrigation; Other: Usual Care

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

Retrograde Colonic Irrigation DEVICE

Retrograde Colonic Irrigation with usual care

Usual Care OTHER

Retrograde Colonic Irrigation with usual care; Usual Care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (6)

CHRU de Lille

Lille, 59037, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CMRRF de Kerpape

Ploemeur, 56275, France

Location

Rennes University Hospital

Rennes, 35000, France

Location

CHU de Rouen

Rouen, 76031, France

Location

CHRU de Nancy-Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• Brochard C, Jezequel M, Blanchard-Dauphin A, Kerdraon J, Perrouin-Verbe B, Leroi AM, Reymann JM, Peyronnet B, Morcet J, Siproudhis L. Transanal irrigation is a better choice for bowel dysfunction in adults with Spina bifida: A randomised controlled trial. Colorectal Dis. 2023 Jun;25(6):1267-1276. doi: 10.1111/codi.16518. Epub 2023 Mar 11.

  PMID: 36799340 RESULT

MeSH Terms

Conditions

Spinal Dysraphism; Encopresis; Constipation; Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Laurent Siproudhis, Md, PhD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 11, 2015
• Study Start: March 16, 2015
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (6)