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

NCT02361450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-05-24

No results posted yet for this study

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

Interventions

DEVICE

Retrograde Colonic Irrigation

OTHER

Usual Care

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Laurent Siproudhis, Md, PhD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-16
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02361450 on ClinicalTrials.gov