Product evaluation of a novel device designed to manage fecal incontinence in hospitalized bed-ridden patients.
- Conditions
- Health Condition 1: null- Fecal Incontinence in bed-ridden patients
- Registration Number
- CTRI/2014/02/004429
- Lead Sponsor
- Consure Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 10
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.
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.
•Unwilling patients.
•Enrolled in another clinical study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢The fecal material diverts into the external collection bag through the device as observed visually. <br/ ><br> <br/ ><br>â?¢There is no visible soiling, leaking or seepage of fecal secretions from the periphery of the device. <br/ ><br> <br/ ><br>â?¢The duration for which the appliance stays on without change or removal. The cause of the change or removal will be documented. <br/ ><br> <br/ ><br>Timepoint: 24 hours to 5 days
- Secondary Outcome Measures
Name Time Method o tear or injury to the ano-rectal mucosa, which will be assessed using a bedside proctoscopic examination after the removal of device.Timepoint: 24 hours to 5 days;No visibility of active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of this device.Timepoint: 24 hours to 5 days;Self-expansion of the fecal incontinence device at the pre-determined location as assessed by an X-ray image.Timepoint: 24 hours to 5 days;The device does not get expelled from the rectum.Timepoint: 24 hours to 5 days;The fecal collection bag does not hinder any patient mobility or standard maneuvering performed on bed-ridden patients.Timepoint: 24 hours to 5 days;There is no dislodgement, tear, tear or obstruction of the lumen of the external collection bag.Timepoint: 24 hours to 5 days;There is no tear, damage, or breakdown of the indwelling device after it has been retrieved from the rectum.Timepoint: 24 hours to 5 days