CLOUDS Study
Research type
Research Study
Full title
CLOUDS Study Cross sectional investigation of burden of disease in newly operated stoma patients
IRAS ID
301896
Contact name
Rachel Ainsworth
Contact email
Sponsor organisation
Coloplast UK & Ireland Ltd
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Post-operative high output and peristomal leaking are associated with increased length of stay, readmission, increased healthcare costs, reduced quality of life and skin complications.
The aim of the proposed multi-centred, cross-sectional study is to provide an insight into the baseline burden of disease and health care resource consumption experienced by stoma patients in the first year following surgery. Study subjects are adults with a stoma (ileostomy or colostomy) created within time since surgery (0-12 months).
The study will be conducted from December 2021 to December 2022. Enrolling up to 200 subjects in the UK. Once enrolled, study subjects will be in the study approximately 1-week.
During the study, subjects will be invited for a nurse lead interview to collect demographics, healthcare utilisation and assessment of peristomal skin condition. Subjects will subsequently be asked to fill out an online survey within 48 hours of the nurse-led interview. After confirming whether subjects completed the online survey, a reminder will be sent within 72 hours of the nurse-led interview.
One week following the initial meeting, the patient will be offered to complete a National Institute for Health Research Patient Research Experience Survey and confirmation of survey receipt will be undertaken.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
21/PR/1574
Date of REC Opinion
22 Dec 2021
REC opinion
Further Information Favourable Opinion