Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury
The study aims to compare a newly developed system for transanal colonic irrigation (Peristeen Anal Irrigation) with a bowel management regime that does not include irrigation in a prospective, randomized trial in spinal cord lesion patients (SCL- patients) with faecal incontinence and/or constipation.
Population; 80 SCL- patients with faecal incontinence and/or constipation from five countries.
Bowel symptom score Neurogenic Bowel Dysfunction score Symptom related quality of life questionnaire Time expenditure for performance of bowel care ans side effects
|Constipation Fecal Incontinence Spinal Cord Injury||Procedure: Transanal irrigation with Peristeen Anal Irrigation||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury - a Prospective, Randomized, Controlled, Multicentre Trial of Transanal Irrigation Vs. Conservative Bowel Management|
- Cleveland Clinic Constipaton Scoring System
- St. Mark's Fecal Incontinence Grading System
- Neurogenic Bowel Dysfunction Score
- American Society of Colorectal Surgeon Fecal Incontinence Score
|Study Start Date:||December 2003|
|Estimated Study Completion Date:||August 2005|
The magnitude of bowel dysfunction in spinal cord injury patients has been documented in several studies. Spinal cord injury affects colorectal motility, transit times, and bowel emptying often leading to constipation, fecal incontinence or a combination of both. Although these symptoms are not life-threatening, they may have a severe impact on quality of life as well as increase levels of anxiety and depression.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286520
|Surgical Research Unit, Department of Surgery P, Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Study Chair:||Soeren Laurberg, professor, D.M.Sci||Surgical Research Unit, Department of Surgery P, Aarhus University Hospital, Denmark|