CTRI/2014/02/004429
Other
N/A
Feasibility and efficacy study of a novel device designed to manage fecal incontinence in hospitalized bed-ridden patients.
Consure Medical Pvt Ltd0 sites10 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Fecal Incontinence in bed-ridden patients
- Sponsor
- Consure Medical Pvt Ltd
- Enrollment
- 10
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients in neurology and critical care ward that require nursing care for the management of fecal incontinence due to a central neurogenic condition. The volunteers should meet all of the following criteria:
- •Patients must be between 18 â?? 75 years of age (Both sexes).
- •Fecal incontinence must be caused due to an intracranial or spinal disorder.
- •Patient is confirmed to have more than 2 stool/bowel episodes in the last 24 hours.
- •Patient has achieved hemodynamic stability.
- •Patient or a legal representative of the patient gives written consent for the study.
Exclusion Criteria
- •Following patients will be not be included in this feasibility study:
- •Fecal incontinence caused due to local causes, i.e. any trauma, disease or condition of the muscular apparatus of the ano\-rectal region.
- •Patients with significant hemorrhoids, growth, ulcers, malignancy, fissure, stricture and local pathology as observed during protoscopic examination. Short\-listed patients with external or internal hemorrhoids that are classified as Grade III or lower can be enrolled in the study.
- •Patients on oral anti\-coagulation.
- •Patients that have planned MRI examination over the duration of the study.
- •Patients with recent history of colo\-rectal surgeries or therapeutic procedures.
- •Patients with or having suspicion of ulcerative colitis, Crohnâ??s disease or rectal ulcers.
- •Patients suspected to have intestinal tuberculosis.
- •Patients on inotropic drugs.
- •Patients with confirmed pregnancy or suspected to be pregnant.
Outcomes
Primary Outcomes
Not specified
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