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

Spina Bifida Clinical Trial

— IRRICO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361450
• Other study ID #: 2013-A01520-45
• Status: Completed
• Phase: N/A
• Start date: March 16, 2015
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spina Bifida
• Spinal Dysraphism

Intervention

Device:
• Retrograde Colonic Irrigation

Other:
• Usual Care

Locations

Country	Name	City	State
France	CHRU de Lille	Lille
France	CHU de Nantes	Nantes
France	CMRRF de Kerpape	Ploemeur
France	Rennes University Hospital	Rennes
France	CHU de Rouen	Rouen
France	CHRU de Nancy-Brabois	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurogenic Bowel Dysfunction (NBD) score		Ten weeks after inclusion
Secondary	Questionnaire data of incontinence and constipation (Cleveland scores)		Ten weeks after inclusion
Secondary	Questionnaire data of incontinence and constipation (Cleveland scores)		Twenty-four weeks after inclusion
Secondary	Quality of life	Quality of life will be assess by semi-quantified scales	Ten weeks after inclusion
Secondary	Quality of life	Quality of life will be assess by semi-quantified scales	Twenty-four weeks after inclusion
Secondary	Self esteem (Rosenberg scale)		Ten weeks after inclusion
Secondary	Functional digestive score (NBD)		Twenty-four weeks after inclusion
Secondary	Cumulative time spent using restrooms	Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Secondary	Cumulative time spent using restrooms	Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Secondary	Number of accidents of incontinence	Number of accidents of incontinence will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Secondary	Number of accidents of incontinence	Number of accidents of incontinence will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Secondary	Number of incontinence guards used	Number of incontinence guards used will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Secondary	Number of incontinence guards used	Number of incontinence guards used will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Secondary	Type of incontinence guards used	Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Secondary	Type of incontinence guards used	Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Secondary	Number of stools	Number of stools will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Secondary	Number of stools	Number of stools will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Secondary	Stools consistency	Stools consistency will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Secondary	Stools consistency	Stools consistency will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Secondary	Symptoms experienced during defecation	Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Secondary	Symptoms experienced during defecation	Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Secondary	Frequency of digital help during defecation	The frequency of digital stimulation will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Secondary	Frequency of digital help during defecation	The frequency of digital stimulation will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion