Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury
| Tracking Information | |||||
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| First Received Date ICMJE | January 30, 2006 | ||||
| Last Updated Date | February 2, 2006 | ||||
| Start Date ICMJE | December 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00286520 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury | ||||
| Official Title ICMJE | 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 | ||||
| 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 and/or constipation. 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Transanal irrigation with Peristeen Anal Irrigation | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 80 | ||||
| Completion Date | August 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00286520 | ||||
| Other Study ID Numbers ICMJE | DK021CC | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | February 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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