A study to evaluate the clinical and health-economic effectiveness of a novel device for faecal management in bed-ridden patients with little to no bowel control

Evaluating the clinical and health-economic effectiveness of a novel device for faecal management in bed-ridden patients with little to no bowel control. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/02/007831

Enrollment

Registered

2017-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Bedridden patients with fecal incontinence

Interventions

Intervention1: Qora Aeon Stool Management Kit: Stool management system for fecal incontinence in bed-ridden patients.Â Control Intervention1: Diapers and Pads: Standard absorbent pads

Eligibility

Inclusion criteria

Inclusion criteria: Male and female patients, more than 18 years of age who have liquid to semi-formed stool Non-ambulatory, hospitalized patients History of passage of at least 1 stool in past 24 hours Patient or a legal representative of the patient gives written consent for the study

Exclusion criteria

Exclusion criteria: Patients enrolled in another clinical study or trial will be excluded.

Design outcomes

Primary

Measure	Time frame
Duration for which the device properly functions within the patient without spontaneous expulsion or removal, up to 29 days.Timepoint: Every 24 hours	—

Secondary

Measure	Time frame
No. diapers, changes/day, dressing/linen changes before/during/after device use Time and no. of care providers required for diaper/linen changes Relative risk, odds ratio of IAD/FAPU Increase in LoS and related clinical management due to IAD/FAPU Time to insert, deploy, maintain device, exchange bags Qualitative caregiver acceptability survey Caregiver strain index before/after study Prevalence of pressure ulcer Avg duration and risk factors for development of pressure ulcer Timepoint: Every 24 Hours	—

Measure

Time frame

No. diapers, changes/day, dressing/linen changes before/during/after device use Time and no. of care providers required for diaper/linen changes Relative risk, odds ratio of IAD/FAPU Increase in LoS and related clinical management due to IAD/FAPU Time to insert, deploy, maintain device, exchange bags Qualitative caregiver acceptability survey Caregiver strain index before/after study Prevalence of pressure ulcer Avg duration and risk factors for development of pressure ulcer Timepoint: Every 24 Hours

—

Countries

India

Contacts

Public ContactAmit Sharma

King Edward Memorial Hospital and Seth G.S. Medical College

ateeshilpa@gmail.com9821114002

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026