Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury
NCT ID: NCT00286520
Last Updated: 2006-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2003-12-31
2005-08-31
Brief Summary
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Population; 80 SCL- patients with faecal incontinence and/or constipation from five countries.
Focus on:
Bowel symptom score Neurogenic Bowel Dysfunction score Symptom related quality of life questionnaire Time expenditure for performance of bowel care ans side effects
Detailed Description
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Various bowel management programs have been empirical, and individual solutions have been sought on a trial-and-error basis. Transanal irrigation has been used in selected patients with constipation or fecal incontinence. The majority of spinal cord injured patients in a recent study benefited from the treatment. However, there is limited evidence in the literature supporting any bowel management program in spinal cord injury in favor of another and well-designed controlled trials are still lacking. Therefore, the present study aims to compare transanal irrigation with conservative bowel management, defined as best supportive bowel care without irrigation, in a prospective, randomized, controlled, multicentre study among spinal cord injured patients with neurogenic bowel dysfunction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Transanal irrigation with Peristeen Anal Irrigation
Eligibility Criteria
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Inclusion Criteria
* Spinal cord lesion at any level at least 3 months from injury
* At least one or more of the following symptoms:
* Spending ½ hour or more attempting to defecate each day or every second day
* Symptoms of autonomic dysreflexia before or during defecation
* Abdominal discomfort before or during defecation
* Episodes of faecal incontinence once or more per month
* The patient is able to understand the treatment and is willing to comply with the prescribed regimen
* The patient is able to perform transanal colonic irrigation seated on a toilet commode with or without assistance
* Signed informed consent has been obtained
Exclusion Criteria
* Perform transanal retrograde irrigation on a regular basis
* Evidence of bowel obstruction
* Evidence of inflammatory bowel disease
* History of cerebral palsy or cerebral apoplexy
* Multiple sclerosis
* Diabetic polyneuropathy
* Previous abdominal or perianal surgery (not including minor surgery as appendectomy or haemorrhoidectomy)
* Pregnant or lactating
* Evidence of spinal chock
* Mentally unstable
* Treatment with more than 5 mg prednisolon per day.
* PNS implant (sacral nerve stimulation)
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Montecatone Rehabilitation Institute S.p.A.
OTHER
National Spinal Injuries Centre, Stoke Mandeville Hospital, United Kingdom,
UNKNOWN
Orthopädische Universitätsklinik Heidelberg, Germany,
UNKNOWN
Karolinska University Hospital
OTHER
Central Jutland Regional Hospital
OTHER
University of Aarhus
OTHER
Principal Investigators
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Soeren Laurberg, professor, D.M.Sci
Role: STUDY_CHAIR
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital, Denmark
Locations
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Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Aarhus, , Denmark
Countries
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References
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Christensen P, Olsen N, Krogh K, Bacher T, Laurberg S. Scintigraphic assessment of retrograde colonic washout in fecal incontinence and constipation. Dis Colon Rectum. 2003 Jan;46(1):68-76. doi: 10.1007/s10350-004-6498-0.
Christensen P, Kvitzau B, Krogh K, Buntzen S, Laurberg S. Neurogenic colorectal dysfunction - use of new antegrade and retrograde colonic wash-out methods. Spinal Cord. 2000 Apr;38(4):255-61. doi: 10.1038/sj.sc.3100991.
Krogh K, Olsen N, Christensen P, Madsen JL, Laurberg S. Colorectal transport during defecation in patients with lesions of the sacral spinal cord. Neurogastroenterol Motil. 2003 Feb;15(1):25-31. doi: 10.1046/j.1365-2982.2003.00381.x.
Other Identifiers
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DK021CC
Identifier Type: -
Identifier Source: org_study_id