Health Condition 1: null- Fecal Incontinence in bed-ridden patients
Conditions
Interventions
Intervention1: Consure SMS 120: Stool management system for fecal incontinence in bed-ridden patients.
Control Intervention1: NIL: NIL
Control Intervention2: NIL: NIL
Sponsors
Consure Medical Pvt Ltd
Eligibility
Inclusion 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
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. • Unwilling patients. • Enrolled in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ The fecal material diverts into the external collection bag through the device as observed visually. â?¢ There is no visible soiling, leaking or seepage of fecal secretions from the periphery of the device. â?¢ The duration for which the appliance stays on without change or removal. The cause of the change or removal will be documented. Timepoint: 24 hours to 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| No 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 | — |
Countries
India
Contacts
Public ContactNish Chasmawala
St. Johns Medical College Hospital
Outcome results
None listed