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Trial record 48 of 6674 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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

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ClinicalTrials.gov Identifier: NCT02361450
Recruitment Status : Recruiting
First Posted : February 11, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment Phase
Spina Bifida Device: Retrograde Colonic Irrigation Other: Usual Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial
Actual Study Start Date : March 16, 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spina Bifida

Arm Intervention/treatment
Experimental: 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.
Device: Retrograde Colonic Irrigation
Other: Usual Care
Active Comparator: Usual Care
In the comparator group, patients will receive conventional care, according to each clinical center habits.
Other: Usual Care



Primary Outcome Measures :
  1. Neurogenic Bowel Dysfunction (NBD) score [ Time Frame: Ten weeks after inclusion ]

Secondary Outcome Measures :
  1. Questionnaire data of incontinence and constipation (Cleveland scores) [ Time Frame: Ten weeks after inclusion ]
  2. Questionnaire data of incontinence and constipation (Cleveland scores) [ Time Frame: Twenty-four weeks after inclusion ]
  3. Quality of life [ Time Frame: Ten weeks after inclusion ]
    Quality of life will be assess by semi-quantified scales

  4. Quality of life [ Time Frame: Twenty-four weeks after inclusion ]
    Quality of life will be assess by semi-quantified scales

  5. Self esteem (Rosenberg scale) [ Time Frame: Ten weeks after inclusion ]
  6. Functional digestive score (NBD) [ Time Frame: Twenty-four weeks after inclusion ]
  7. Cumulative time spent using restrooms [ Time Frame: Ten weeks after inclusion ]
    Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire

  8. Cumulative time spent using restrooms [ Time Frame: Twenty-four weeks after inclusion ]
    Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire

  9. Number of accidents of incontinence [ Time Frame: Ten weeks after inclusion ]
    Number of accidents of incontinence will be collected with a patient reported outcome questionnaire

  10. Number of accidents of incontinence [ Time Frame: Twenty-four weeks after inclusion ]
    Number of accidents of incontinence will be collected with a patient reported outcome questionnaire

  11. Number of incontinence guards used [ Time Frame: Ten weeks after inclusion ]
    Number of incontinence guards used will be collected with a patient reported outcome questionnaire

  12. Number of incontinence guards used [ Time Frame: Twenty-four weeks after inclusion ]
    Number of incontinence guards used will be collected with a patient reported outcome questionnaire

  13. Type of incontinence guards used [ Time Frame: Ten weeks after inclusion ]
    Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire

  14. Type of incontinence guards used [ Time Frame: Twenty-four weeks after inclusion ]
    Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire

  15. Number of stools [ Time Frame: Ten weeks after inclusion ]
    Number of stools will be collected with a patient reported outcome questionnaire

  16. Number of stools [ Time Frame: Twenty-four weeks after inclusion ]
    Number of stools will be collected with a patient reported outcome questionnaire

  17. Stools consistency [ Time Frame: Ten weeks after inclusion ]
    Stools consistency will be collected with a patient reported outcome questionnaire

  18. Stools consistency [ Time Frame: Twenty-four weeks after inclusion ]
    Stools consistency will be collected with a patient reported outcome questionnaire

  19. Symptoms experienced during defecation [ Time Frame: Ten weeks after inclusion ]
    Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire

  20. Symptoms experienced during defecation [ Time Frame: Twenty-four weeks after inclusion ]
    Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire

  21. Frequency of digital help during defecation [ Time Frame: Ten weeks after inclusion ]
    The frequency of digital stimulation will be collected with a patient reported outcome questionnaire

  22. Frequency of digital help during defecation [ Time Frame: Twenty-four weeks after inclusion ]
    The frequency of digital stimulation will be collected with a patient reported outcome questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361450


Contacts
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Contact: Laurent Siproudhis, Md, PhD laurent.siproudhis@chu-rennes.fr

Locations
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France
CHRU de Lille Recruiting
Lille, France, 59037
Principal Investigator: Anne Blanchard-Dauphin, Md, PhD         
Hôpital de la Timone Not yet recruiting
Marseille, France, 13354
Principal Investigator: Jean-Michel GUYS, PhD         
Hôpital Nord Not yet recruiting
Marseille, France, 13354
Principal Investigator: Véronique Vitton, PhD         
CHU de Nantes Recruiting
Nantes, France, 44093
Principal Investigator: Perrouin Verbe, Md PhD         
CMRRF de Kerpape Recruiting
Ploemeur, France, 56275
Principal Investigator: Jacques KERDRAON, Md         
Rennes University Hospital Recruiting
Rennes, France, 35000
Contact       laurent.siproudhis@chu-rennes.fr   
Principal Investigator: Laurent Siproudhis, Md, PhD         
CHU de Rouen Recruiting
Rouen, France, 76031
Principal Investigator: Anne-Marie LEROI, Md, PhD         
CHRU de Nancy-Brabois Not yet recruiting
Vandoeuvre les Nancy, France, 54511
Principal Investigator: Jean-Louis LEMELLE, Md, PhD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Laurent Siproudhis, Md, PhD Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02361450     History of Changes
Other Study ID Numbers: 2013-A01520-45
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Keywords provided by Rennes University Hospital:
Faecal incontinence
Spina Bifida
Enema
Constipation
Myelomeningocele
Human
Additional relevant MeSH terms:
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Spinal Dysraphism
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities