Burden of disease in newly operated stoma (an opening to allow faeces to be diverted out of the body) patients
| ISRCTN | ISRCTN23080097 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23080097 |
| IRAS number | 301896 |
| Secondary identifying numbers | CIPUK01, IRAS 301896, CPMS 49866 |
- Submission date
- 26/01/2022
- Registration date
- 04/02/2022
- Last edited
- 24/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
A colostomy is an operation to divert one end of the colon (part of the bowel) through an opening in the belly. The opening is called a stoma. A pouch can be placed over the stoma to collect your poo (stools).
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.
Who can participate?
Study subjects are adults with a stoma (ileostomy or colostomy) created within time since surgery (0-12 months).
What does the study involve?
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.
What are the possible benefits and risks of participating?
This survey-based study presents minimal risk to participants and we have not identified any ethical or legal issues specific to this study. There are no direct benefits associated with participation in this study, other than the information collected in this study will be added to the current knowledge and understanding of patient burden in this disease
Where is the study run from?
The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2021 to June 2023
Who is funding the study?
Coloplast UK & Ireland Ltd.
Who is the main contact?
Rachel Ainsworth, gbrah@coloplast.com
Dr Richard Brady, richard.brady32@nhs.net
Contact information
Public
Coloplast Ltd
Nene Hall
Peterborough Business Park
Peterborough
PE2 6FX
United Kingdom
| Phone | +44 (0)1733392000 |
|---|---|
| gbrhc@coloplast.com |
Scientific
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Gosforth
Newcastle upon Tyne
NE3 3HD
United Kingdom
| Phone | +44 1912820488 |
|---|---|
| richard.brady32@nhs.net |
Principal Investigator
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Gosforth
Newcastle upon Tyne
NE3 3HD
United Kingdom
| Phone | +44 1912820488 |
|---|---|
| richard.brady32@nhs.net |
Study information
| Study design | Multi-centred cross-sectional investigation |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 41022 PIS V2.0 15Dec21.pdf |
| Scientific title | CLOUDS-Study: Cross-sectional investigation of burden of disease in newly operated stoma patients |
| Study acronym | CLOUDS |
| Study hypothesis | There is significant impact from the burden of disease in post-operative stoma patients. |
| Ethics approval(s) | Approved 22/12/2021, London - Bloomsbury Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 2071048071; bloomsbury.rec@hra.nhs.uk), ref: 21/PR/1574 |
| Condition | People with a stoma |
| Intervention | The investigation is a cross-sectional, multi-centred study, evaluating the burden of disease by an interview and online questionnaire with an expected duration of 1 week. All visits will be planned to be remote visits, if technically possible. If a remote visit is not possible, a face-to-face meeting will be scheduled, either at subjects’ own home or at site. Once consent has been obtained at an Enrolment/Inclusion Visit (Visit 0), subjects will attend a nurse interview visit (Visit 1) during which the following activities will take place: 1) confirmation of consent; 2) collecting demographic information, healthcare utilisation and peristomal skin condition information; 3) training the subjects on the online survey system and 4) subjects completing baseline questions in the online survey system. Further surveys will be accessed by the patient in the online system at a time of their convenience and completed over the course of the next 48 hours. Subjects will be called within 72 hours to confirm that surveys have been completed (Visit 2, Survey follow-up). One week following Visit 1 (unless the patient is planned for a further remote meeting) the patient will be offered to complete a NIHR Patient Research Experience Survey (PRES) and confirmation of survey receipt will be undertaken. If the patient is due to have a further meeting to assist them complete the survey, they will be offered to complete the patient research experience questionnaire at the same time (Visit 3, Participant in Research Experience Survey). |
| Intervention type | Other |
| Primary outcome measure | Patient-reported number of times with stoma effluent leakage outside the baseplate (e.g. onto clothes or bed sheets) within the last 2 weeks, collected using an online survey completed by subjects within 48 hours of nurse-led interview visit (Visit 1). |
| Secondary outcome measures | 1. Leakage-related quality of life & Impact, measured using Ostomy Lead Impact (OLI) questionnaire within 48 hours of nurse-led interview visit (Visit 1) 2. Patient self-management, measured using Patient Activation Measurement (PAM) questionnaire within 48 hours of nurse-led interview visit (Visit 1) 3. Health-related quality of life, measured using EQ-5D-5L questionnaire within 48 hours of nurse-led interview visit (Visit 1) 4. Peristomal skin condition measured using Decision Tree Score based on Ostomy Skin Tool 2.0 at nurse-led interview visit (Visit 1) and online survey within 48 hours of nurse-led interview visit (Visit 1) 5. Mental wellbeing measured using WHO-5 Well-Being Index within 48 hours of nurse-led interview visit (Visit 1) 6. Worry about leakage and actions taken when worrying using online survey within 48 hours of nurse-led interview visit (Visit 1) 7. Odor assessed using online survey within 48 hours of nurse-led interview visit (Visit 1) 8. Changing routine (wear time,reason for change and accessories use) assessed using online survey within 48 hours of nurse-led interview visit (Visit 1) 9. Unplanned changes due to leakage worry assessed using online survey within 48 hours of nurse-led interview visit (Visit 1) 10. Self-management (feeling of security, confidence in knowing when to change appliance and confidence at night) assessed using online survey within 48 hours of nurse-led interview visit (Visit 1) 11. Impact of leakage on work (sick days), sleep and social activities (2 week recall) assessed using online survey within 48 hours of nurse-led interview visit (Visit 1) 12. Healthcare resource utilisation (2 week recall) assessed at nurse-led interview visit (Visit 1) |
| Overall study start date | 01/01/2021 |
| Overall study end date | 16/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | The investigation aims to include minimum 120 and maximum 200 subjects |
| Total final enrolment | 117 |
| Participant inclusion criteria | 1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Have had their stoma for less than 12 months 4. Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7) 5. Have intact skin on the peristomal area (assessed by investigator) 6. Have been self-managing stoma appliance for at least 14 days. 7. Must be able to complete the online survey via the EDC system |
| Participant exclusion criteria | 1. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tab-let/injection) treatment. 2. Have previously participated in this investiga-tion. 3. Patients with a complicated stoma at baseline (dehiscence/prolapse/hernia) 4. Having more than one abdominal stoma simul-taneously present. 5. Ongoing non-healed abdominal wounds 6. Reoperation / stoma reversal planned prior to completion of first study visit or questionnaire assessments. 7. Limited life expectancy / palliative care patients 8. Stage 4 cancer patients 9. Enrolment into an interventional stoma/stoma device trial within the last 12 months |
| Recruitment start date | 15/02/2022 |
| Recruitment end date | 16/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Newcastle upon Tyne
Newcastle upon Tyne
NE3 3HD
United Kingdom
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Gorleston-on-Sea
Great Yarmouth
NR31 6LA
United Kingdom
Sponsor information
Industry
Peterborough Business Park
Peterborough
PE2 6FX
England
United Kingdom
| Phone | +447469155842 |
|---|---|
| gbrah@coloplast.com | |
| Website | https://www.coloplast.co.uk |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| Publication and dissemination plan | The results from this study will be submitted to regulatory authorities, as required, and for publication in a peer-reviewed journal. The results will also be presented at conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository by the study Sponsor The name of the repository: data will be stored in Coloplast's internal filing system The type of data stored: all data collected during the study The process for requesting access (if non-publicly available): N/A; not available to the public Dates of availability: N/A Whether consent from participants was required and obtained: Yes Comments on data anonymization: no identifiable data is stored in the filing system; subjects are identified with a unique study identifier |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 15/12/2021 | 04/02/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | 02/09/2024 | 02/09/2024 | No | No |
Additional files
Editorial Notes
24/09/2024: The intention to publish date was changed from 31/12/2023 to 31/03/2025. IPD sharing plan added.
02/09/2024: Basic results and total final enrolment added.
31/07/2024: Contact details updated.
13/07/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 24/03/2023 to 16/06/2023.
2. The overall end date was changed from 31/03/2023 to 16/06/2023.
3. The plain English summary was updated to reflect these changes.
10/11/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/12/2022 to 24/03/2023.
2. The overall trial end date was changed from 31/12/2022 to 31/03/2023.
3. Leeds Institute of Medical and Clinical Sciences was removed and Lancashire Teaching Hospitals NHS Foundation Trust and James Paget University Hospitals NHS Foundation Trust were added to the trial participating centres.
02/03/2022: Internal review.
04/02/2022: Trial's existence confirmed by London - Bloomsbury Research Ethics Committee.
