Reinforcement of closure of stoma site using a biological mesh – extended follow-up
| ISRCTN | ISRCTN25584182 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25584182 |
| IRAS number | 077075 |
| Secondary identifying numbers | CPMS 49449, NIHR202011, IRAS 077075 |
- Submission date
- 28/04/2022
- Registration date
- 10/05/2022
- Last edited
- 12/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
An incisional hernia forms when a surgical wound fails to heal and a defect remains in the muscle wall. Closure of a stoma wound (stomas are formed when the bowel is brought to the tummy skin) is a frequent cause of incisional hernia, occurring in over 1,000 UK patients every year. Surgical repair of these hernias is hazardous and up to 1 in 2 repairs will fail. These patients can be elderly with multiple medical problems, so further attempts at repair may be too risky, meaning they must tolerate the symptoms of pain, swelling and discomfort and live with the risk of life-threatening complications. A treatment that reduces the occurrence of hernias after stoma closure would improve patients’ quality of life, reduce surgical complications and remove the need for further operations. The ROCSS study sought to address this problem by the use of a mesh to support the wound while it heals. Meshes are widely used in hernia repair to support the muscles while they heal. However, the mesh increases the problems of infection when the wound is contaminated by bacteria (as is the case in stoma closure). In ROCSS a type of ‘biological’ mesh made from animal tissue which is incorporated into the body tissues was used. Animal and human studies indicate that long-term infection problems are, as a consequence, reduced. ROCSS showed ROCSS was that fewer patients in the mesh group had a detectable hernia after 2 years – nearly half the number of participants compared to those who did not get a mesh.
The ROCSS study was trying to find out if the mesh works or not at reducing the development of hernias. We believe that more people will form hernias over time, and these may require treatment and impact of peoples’ quality of life. We aim to investigate this in the ROCSS-EX study.
Who can participate?
Patients who took part in the original ROCSS study in the UK who successfully has their stoma reversed.
What does the study involve?
ROCSS-EX does not involve any additional treatment, tests or hospital visits. The extend follow-up involves a one-off telephone consultation to ask questions about quality of life the reversal operation and any symptoms related to the abdominal wall. It will also involve a review of health records to assess if any additional treatments may have been required in relation to the closed stoma site, reducing the number of questions asked during the telephone consultation.
What are the possible benefits and risks of participating?
There are no risks associated with taking part as this study involves only a telephone consultation.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
November 2020 to August 2022
Who is funding the study?
National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) (NIHR212020) (UK).
Who is the main contact?
Ruth Evans, Trial Manager, rocss@trials.bham.ac.uk
Contact information
Public
Birmingham Clinical Trials Unit
Public Health Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0003-4513-1509 |
|---|---|
| Phone | +44 121 414 9012 |
| rocss@trials.bham.ac.uk |
Scientific
Institute of Cancer and Genomics
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| ORCID ID |
0000-0001-5889-4391 |
|---|---|
| ruth.benson@gmail.com |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Extended follow-up of the ROCSS trial |
| Study acronym | ROCSS-EX |
| Study hypothesis | Is there a significant improvement in long-term quality of life for patients that have a biological mesh reinforcement of the abdominal wall at the time of closure of stoma site, and is the intervention cost-effective? An extended follow up of the ROCSS study (https://www.isrctn.com/ISRCTN46330337) |
| Ethics approval(s) | Approved 07/01/2021, West Midlands - Coventry & Warwickshire Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 207 104 8009; coventryandwarwick.rec@hra.nhs.uk), ref: 12/WM/0187 |
| Condition | Incisional hernia |
| Intervention | There is no intervention if ROCSS-EX as such as it extended follow-up – the intervention under investigation remains the same one as in the original ROCSS trial (Reinforcement of the stoma closure site using the Strattice® collagen mesh). (https://www.isrctn.com/ISRCTN46330337) |
| Intervention type | Other |
| Primary outcome measure | Quality of life at 5 to 8 years following closure of stoma site comparing participants who had mesh reinforcement of their abdominal wall with participants that had a standard closure. This will be assessed using the HerQLes tool |
| Secondary outcome measures | At 5-8 years follow-up: 1. Participant reported incisional hernia rate 2. Number of hospital visits for any hernia related reason 3. Number of interventional procedures related to the stoma closure site or hernia 4. Longitudinal QoL assessed using EQ-5D 5. Cost analysis for all additional hernia related events |
| Overall study start date | 01/11/2020 |
| Overall study end date | 31/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 702; UK Sample Size: 702 |
| Total final enrolment | 406 |
| Participant inclusion criteria | All participants included in the ROCSS trial are eligible to be included in ROCSS-EX unless they withdrew or did not have their stoma reversed during the duration of the original trial. those participants who have died, only routinely collected data will be used. |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/02/2021 |
| Recruitment end date | 31/05/2021 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Bordesley Green
Birmingham
B9 5SS
United Kingdom
Bristol
BS2 8HW
United Kingdom
Broomfield
Chelmsford
CM1 7ET
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Princes Street
Dorchester
DT1 1TS
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Mansfield Road
Sutton-in-Ashfield
NG17 4JL
United Kingdom
Leicester
LE5 4PW
United Kingdom
Leicester
LE1 5WW
United Kingdom
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Walsall
WS2 9PS
United Kingdom
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Boston
PE21 9QS
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Margate
CT9 4AN
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Inverness
IV2 3UJ
United Kingdom
Wigan
WN1 2NN
United Kingdom
Stoke-on-trent
ST4 6QG
United Kingdom
Bath Business Park
Peasedown St. John
Bath
BA2 8SG
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
West Bromwich
B71 4HJ
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Spitalfield Lane
Chichester
PO19 6SE
United Kingdom
Walsgrave
Coventry
CV2 2DX
United Kingdom
Stockton-on-tees
TS19 8PE
United Kingdom
Worcester
WR5 1ZL
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
York
YO31 8HE
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Manjinder Kaur (m.kaur@bham.ac.uk/rocss@trials.bham.ac.uk) . Access to anonymised data may be granted following review. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 8.0 | 12/01/2021 | 30/08/2022 | No | No |
| Results article | 02/08/2024 | 12/08/2024 | Yes | No |
Additional files
Editorial Notes
12/08/2024: Publication reference added.
15/12/2022: The intention to publish date was changed from 31/12/2022 to 30/06/2023.
30/08/2022: The following changes have been made:
1. The condition has been changed from "Hernia surgery" to "Incisional hernia".
2. The final enrolment number has been added.
3. Norfolk & Norwich University Hospital has been added to the trial participating centres.
4. The sponsor contact email has been added.
5. The plain English summary has been updated with the public contact's email address.
6. A protocol file has been uploaded.
11/07/2022: The scientific contact email was updated.
28/04/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
