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

Primary Purpose

Spina Bifida

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Retrograde Colonic Irrigation
Usual Care
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spina Bifida focused on measuring Faecal incontinence, Spina Bifida, Enema, Constipation, Myelomeningocele, Human

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • CHRU de Lille
  • CHU de Nantes
  • CMRRF de Kerpape
  • Rennes University Hospital
  • CHU de Rouen
  • CHRU de Nancy-Brabois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Retrograde Colonic Irrigation with usual care

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Neurogenic Bowel Dysfunction (NBD) score

Secondary Outcome Measures

Questionnaire data of incontinence and constipation (Cleveland scores)
Questionnaire data of incontinence and constipation (Cleveland scores)
Quality of life
Quality of life will be assess by semi-quantified scales
Quality of life
Quality of life will be assess by semi-quantified scales
Self esteem (Rosenberg scale)
Functional digestive score (NBD)
Cumulative time spent using restrooms
Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire
Cumulative time spent using restrooms
Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire
Number of accidents of incontinence
Number of accidents of incontinence will be collected with a patient reported outcome questionnaire
Number of accidents of incontinence
Number of accidents of incontinence will be collected with a patient reported outcome questionnaire
Number of incontinence guards used
Number of incontinence guards used will be collected with a patient reported outcome questionnaire
Number of incontinence guards used
Number of incontinence guards used will be collected with a patient reported outcome questionnaire
Type of incontinence guards used
Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire
Type of incontinence guards used
Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire
Number of stools
Number of stools will be collected with a patient reported outcome questionnaire
Number of stools
Number of stools will be collected with a patient reported outcome questionnaire
Stools consistency
Stools consistency will be collected with a patient reported outcome questionnaire
Stools consistency
Stools consistency will be collected with a patient reported outcome questionnaire
Symptoms experienced during defecation
Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire
Symptoms experienced during defecation
Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire
Frequency of digital help during defecation
The frequency of digital stimulation will be collected with a patient reported outcome questionnaire
Frequency of digital help during defecation
The frequency of digital stimulation will be collected with a patient reported outcome questionnaire

Full Information

First Posted
February 2, 2015
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02361450
Brief Title
Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial
Acronym
IRRICO
Official Title
Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2015 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida
Keywords
Faecal incontinence, Spina Bifida, Enema, Constipation, Myelomeningocele, Human

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retrograde Colonic Irrigation with usual care
Arm Type
Experimental
Arm Description
In the experimental group, retrograde colonic irrigation sessions will be scheduled in addition to conventional treatment according to a progressive volume program.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
In the comparator group, patients will receive conventional care, according to each clinical center habits.
Intervention Type
Device
Intervention Name(s)
Retrograde Colonic Irrigation
Intervention Type
Other
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Neurogenic Bowel Dysfunction (NBD) score
Time Frame
Ten weeks after inclusion
Secondary Outcome Measure Information:
Title
Questionnaire data of incontinence and constipation (Cleveland scores)
Time Frame
Ten weeks after inclusion
Title
Questionnaire data of incontinence and constipation (Cleveland scores)
Time Frame
Twenty-four weeks after inclusion
Title
Quality of life
Description
Quality of life will be assess by semi-quantified scales
Time Frame
Ten weeks after inclusion
Title
Quality of life
Description
Quality of life will be assess by semi-quantified scales
Time Frame
Twenty-four weeks after inclusion
Title
Self esteem (Rosenberg scale)
Time Frame
Ten weeks after inclusion
Title
Functional digestive score (NBD)
Time Frame
Twenty-four weeks after inclusion
Title
Cumulative time spent using restrooms
Description
Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire
Time Frame
Ten weeks after inclusion
Title
Cumulative time spent using restrooms
Description
Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire
Time Frame
Twenty-four weeks after inclusion
Title
Number of accidents of incontinence
Description
Number of accidents of incontinence will be collected with a patient reported outcome questionnaire
Time Frame
Ten weeks after inclusion
Title
Number of accidents of incontinence
Description
Number of accidents of incontinence will be collected with a patient reported outcome questionnaire
Time Frame
Twenty-four weeks after inclusion
Title
Number of incontinence guards used
Description
Number of incontinence guards used will be collected with a patient reported outcome questionnaire
Time Frame
Ten weeks after inclusion
Title
Number of incontinence guards used
Description
Number of incontinence guards used will be collected with a patient reported outcome questionnaire
Time Frame
Twenty-four weeks after inclusion
Title
Type of incontinence guards used
Description
Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire
Time Frame
Ten weeks after inclusion
Title
Type of incontinence guards used
Description
Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire
Time Frame
Twenty-four weeks after inclusion
Title
Number of stools
Description
Number of stools will be collected with a patient reported outcome questionnaire
Time Frame
Ten weeks after inclusion
Title
Number of stools
Description
Number of stools will be collected with a patient reported outcome questionnaire
Time Frame
Twenty-four weeks after inclusion
Title
Stools consistency
Description
Stools consistency will be collected with a patient reported outcome questionnaire
Time Frame
Ten weeks after inclusion
Title
Stools consistency
Description
Stools consistency will be collected with a patient reported outcome questionnaire
Time Frame
Twenty-four weeks after inclusion
Title
Symptoms experienced during defecation
Description
Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire
Time Frame
Ten weeks after inclusion
Title
Symptoms experienced during defecation
Description
Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire
Time Frame
Twenty-four weeks after inclusion
Title
Frequency of digital help during defecation
Description
The frequency of digital stimulation will be collected with a patient reported outcome questionnaire
Time Frame
Ten weeks after inclusion
Title
Frequency of digital help during defecation
Description
The frequency of digital stimulation will be collected with a patient reported outcome questionnaire
Time Frame
Twenty-four weeks after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Siproudhis, Md, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CMRRF de Kerpape
City
Ploemeur
ZIP/Postal Code
56275
Country
France
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHRU de Nancy-Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
36799340
Citation
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.
Results Reference
result

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

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