ROCSS: A randomised controlled trial of reinforcement of closure of stoma site using a biological mesh

Trial Overview

Acronym	ROCSS
Number	46330337
Protocol Link	http://www.birmingham.ac.uk/Documents/college-mds/trials/bctu/ROCSS/Protocol/ROCSS-Protocol-v5.0-01-June-2015.pdf
Public Trial Registry Link	http://www.isrctn.com/ISRCTN46330337
Published Results Link	http://link.springer.com/article/10.1007/s10151-013-1001-3
Status	Closed
Category	Miscellaneous
Treatment Course	Surgery

Trial Description

ROCSS is a RCT assessing the placement of a biological mesh at the site of stoma closure on clinical hernia rate. Our hypothesis is that reinforcing the stoma closure site with a collagen mesh is superior to the standard technique in preventing herniation at 2 years.

Chief Investigator

Dion Morton
Professor

Profile Link

Lead Centre

University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Medical Centre, Mindelsohn Way
Birmingham
B15 2PR
UK

Website

Collaboration and Funding

Collaborative Sites

1. Sandwell & West Birmingham Hospitals NHS Trust-Sandwell General Hospital
Lyndon
West Bromwich
B71 4HJ
UK
Website

2. Sandwell & West Birmingham Hospitals NHS Trust-Birmingham City Hospital
Dudley Road
Birmingham
B18 7QH
UK
Website

3. Yeovil District Hospital NHS Foundation Trust-Yeovil District Hospital,
Yeovil
BA21 4AT
UK
Website

4. Walsall Healthcare NHS Trust-Walsall Manor Hospital
Moat Road
Walsall
WS2 9PS
UK
Website

5. Wrightington, Wigan and Leigh NHS Foundation Trust-Royal Albert Edward Infirmary
Wigan Lane
WN1 2NN
Wigan
UK
Website

6. University Hospitals Coventry and Warwickshire NHS Trust-University Hospital
Clifford Bridge Road
Coventry
CV2 2DX
UK
Website

7. Dorset County Hospital NHS Foundation Trust-Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
UK
Website

8. University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
UK
Website

9. Norfolk and Norwich University Hospitals NHS Foundation Trust-Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
UK
Website

10. Nottingham University Hospitals NHS Trust-Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
UK
Website

11. Doncaster and Bassetlaw Hospitals NHS Foundation Trust-Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
UK
Website

12. Salisbury NHS Foundation Trust
Salisbury
SP2 8BJ
UK
Website

13. Chesterfield Royal Hospital NHS Foundation Trust-Chesterfield Royal Hospital,
Calow
Chesterfield
S44 5BL
UK
Website

14. NHS Highland-Raigmore Hospital
Old Perth Road
Inverness
IV2 3UJ
UK
Website

15. Heart of England NHS Foundation Trust-Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5ST
UK
Website

16. The Royal Wolverhampton NHS Trust-New Cross Hospital
Wolverhampton Road
Wolverhampton
WV10 0QP
UK
Website

17. Royal United Hospital Bath NHS Trust-Royal United Hospital
Combe Park
Bath
BA1 3NG
UK
Website

18. North Tees and Hartlepool NHS Foundation Trust-University Hospital of North Tees
Hardwick
Stockton on Tees
TS19 8PE
UK
Website

19. Tameside Hospital NHS Foundation Trust-Tameside General Hospital
Fountain Street
Ashton-under-Lyne
OL6 9RW
UK
Website

20. University Hospital of South Manchester NHS Foundation Trust-Wythenshawe Hospital
Southmoor Road
Wythenshawe
M23 9LT
UK
Website

Funding Sponsors

Additional Information

Full Research Summary

Objective:	Pragmatic, prospective phase III, multi-centre randomised clinical trial to determine if the use of a collagen tissue matrix/biological mesh reduces the incidence of clinically detectable stoma closure site hernias at two years as compared to standard closure techniques.
Aim:	PRIMARY OBJECTIVE Assess herniation rates detected by clinical examination at two years post randomisation. SECONDARY OBJECTIVES Assess radiological hernia rates at one year post randomisation. Assess surgical re-intervention rates. Assess the frequency of wound infections and seroma associated with the mesh. Assess the impact of the mesh on a patient?s quality of life and any pain experienced. Quality of life an important secondary outcome measure, as the re-operation rate may be low, as even if a clinical hernia is diagnosed, the decision for surgical re-intervention has to take into account the patient?s age, any co-morbidities and patient preference. Determine the cost effectiveness of the mesh insertion in stoma site closure and management of subsequent hernias. Conduct an exploratory analysis to investigate the CT scan as an early surrogate marker of late clinical herniation. Radiological hernia rate at one year post randomisation will be compared with the clinical hernia rate at two years to assess the value of using a CT scan as an early diagnostic tool of herniation. This will identify to other investigators that this is a potential area of clinical need and allow earlier reporting of future studies.
Methods:	Patients undergoing elective closure of the stoma site will be randomised in a 1:1 ratio between: 1) Stoma closure site reinforcement using the biological mesh Vs. 2) Control - standard closure without mesh A minimisation procedure using a computer-based algorithm was used to avoid chance imbalances in important prognostic variables. The minimisation variables were: 1. Stoma type ileostomy versus colostomy. 2. Surgical incision - reopening of midline wound or stoma site only. 3. Skin closure type ? primary or secondary. The original sample size was increase from 560 to 790, which improve the statistical power from 80% to 90%. The trial is looking for a 40% proportional reduction in herniation (25% to 15%). The eligibly requirements for participation in the trial were: ? Inclusion Criteria o Required an elective closure of an ileostomy or a colostomy. o Abel and willing to provide written informed consent for the study. o Aged 18 years or over. ? Exclusion Criteria o Taking part in another clinical study which is related to the surgical procedure. o Allergic to any porcine or collagen products. o Unable or unwilling to provide written informed consent. o History of familial adenomatous polyposis. o Surgeon determined that a mesh repair was definitely required e.g. due to large parastomal hernia.
Reason for International Trial:	To establish an international network that will be utilised for future trials.

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Trial Details

ROCSS: A randomised controlled trial of reinforcement of closure of stoma site using a biological mesh

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

Research

Why join us?

Members

Research

Education

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About ESCP

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Trial Details

ROCSS: A randomised controlled trial of reinforcement of closure of stoma site using a biological mesh

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

Research

Why join us?

Members

Research

Education

News & Events

About ESCP

Contact Us

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