Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286520
Status:
COMPLETED
Last Update Posted:
2006-02-03
First Post:
2006-01-30
Brief Title:
Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor constipation
Population 80 SCL- patients with faecal incontinence andor 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
Population 80 SCL- patients with faecal incontinence andor 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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None