Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
790 participants
INTERVENTIONAL
2012-11-30
2018-05-18
Brief Summary
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Detailed Description
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Hernia at the site of stoma closure occurs in up to 30% of patients and is associated with adverse effects on quality of life. In up to 10% of cases, patients are submitted to complex re-operation which carries significant morbidity. Not all patients will report symptoms or undergo repair, as they do not wish to have a further major operation. Incisional hernias at the site of stomas closure form an important and well defined subgroup. If there is a measurable benefit from mesh insertion, elective use of a collagen mesh would warrant consideration in the closure of other difficult, contaminated abdominal wounds. This study will also provide useful information on the value of using a CT scan as an early diagnostic tool of herniation, which could then be used in future abdominal wall studies as a surrogate endpoint for clinical hernia.
ROCSS aims to assess whether a biological mesh (collagen tissue matrix) reduces the incidence of clinically detectable stoma closure site hernias at two years compared to standard closure techniques. The primary outcome is Occurrence of clinically detectable hernias at two years post randomisation. Other outcomes include surgical re-intervention rate, surgical complications at 30 days post-operation and 1 year post-randomisation, quality of life and post-operative pain, cost-benefit analysis and radiological hernia rate at one year post-randomisation (an exploratory analysis will compare radiological hernia rate at 1 year with clinical hernia rate at 2 years to assess the value of using a CT scan as an early diagnostic tool of incisional hernias).
Randomisation is 1:1 between Strattice® mesh vs. standard closure. The sample size for the trial is 560 (80% power, 10% dropout/crossover, 40% proportional reduction - 25% to 15%) and recruitment will be over 2 years from at least 30 centres. ROCSS will be a double blind (observer blind) randomised controlled trial with a CT scan at one year and clinical follow up at 2 years. Cost benefit analysis and quality of life analysis will be performed at 2 years. The sample size will be reviewed prior to reaching target and may be increased 790 (90% power, 20% dropout/crossover, 40% proportional reduction - 25% to 15%).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Strattice™ Reconstructive Tissue Matrix
Strattice(TM) Reconstructive Tissue Matrix will be placed intra-peritoneally fashion. Once correctly placed, the fascia above will be closed using Prolene, PDS or Nylon (surgeon preference, but excluding Vicryl).
Strattice™ Reconstructive Tissue Matrix
The protocol preference is for the mesh to be placed intra-peritoneally fashion (i.e. below the peritoneum). Anchoring bites will be taken in four to six sites of peritoneum (e.g. using 2-0 PDS) and the mesh will be 'parachuted' into place. Once correctly placed, the fascia above will be closed using Prolene, PDS or Nylon (surgeon preference, but excluding Vicryl). Infiltration of up to 40ml 0.25% Marcaine for infiltration into the fascial layer is recommended. The remainder of the closure will be at the surgeon's discretion.
Standard closure
Fascial closure will be the preferred technique of the surgeon without mesh reinforcement. The technique recommended is the fascia should be closed with Prolene, PDS or nylon sutures; Vicryl should not be used for the fascia. This technique can include either interrupted or continuous sutures.
Closure of the muscle, soft tissues and skin is up to the discretion of the operating surgeon.
Standard Closure
The non-intervention arm for fascial closure will be the preferred technique of the surgeon without mesh reinforcement. The fascia should be closed with Prolene, PDS or nylon sutures; Vicryl should not be used for the fascia. The remainder of the closure will be at the surgeon's discretion.
Interventions
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Strattice™ Reconstructive Tissue Matrix
The protocol preference is for the mesh to be placed intra-peritoneally fashion (i.e. below the peritoneum). Anchoring bites will be taken in four to six sites of peritoneum (e.g. using 2-0 PDS) and the mesh will be 'parachuted' into place. Once correctly placed, the fascia above will be closed using Prolene, PDS or Nylon (surgeon preference, but excluding Vicryl). Infiltration of up to 40ml 0.25% Marcaine for infiltration into the fascial layer is recommended. The remainder of the closure will be at the surgeon's discretion.
Standard Closure
The non-intervention arm for fascial closure will be the preferred technique of the surgeon without mesh reinforcement. The fascia should be closed with Prolene, PDS or nylon sutures; Vicryl should not be used for the fascia. The remainder of the closure will be at the surgeon's discretion.
Eligibility Criteria
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Inclusion Criteria
* Able and willing to provide written informed consent.
* Aged 18 years or over.
Exclusion Criteria
* Allergic to any porcine or collagen products.
* History of familial adenomatous polyposis, due to increased risk of desmoid tumours.
* The surgeon determines that a mesh repair will definitely be required e.g. due to large parastomal hernia.
* Unable or unwilling to provide written informed consent.
18 Years
ALL
No
Sponsors
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LifeCell
INDUSTRY
University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Dion G Morton, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Colorectal Surgery
Locations
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Hvidovre Hospital
Copenhagen, , Denmark
Academisch Medisch Centrum
Amsterdam, , Netherlands
Tameside General Hospital
Ashton-under-Lyne, , United Kingdom
Royal United Hospital Bath
Bath, , United Kingdom
Heart of England NHS Foundation Trust
Birmingham, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Sandwell General Hospital
Birmingham, , United Kingdom
Pilgrim Hospital
Boston, , United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
Broomfield Hospital
Chelmsford, , United Kingdom
St Peters Hospital
Chertsey, , United Kingdom
Chesterfield Royal Hospital
Chesterfield, , United Kingdom
Western Sussex Hospitals NHS Foundation Trust
Chichester, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Doncaster Royal Infirmary
Doncaster, , United Kingdom
Dorset Country Hospital
Dorchester, , United Kingdom
James Paget University Hospital
Great Yarmouth, , United Kingdom
St Marks Hospital
Harrow, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Macclesfield District General Hospital
Macclesfield, , United Kingdom
Queen Elizabeth the Queen Mother Hospital
Margate, , United Kingdom
Norfolk & Norwich University Hospital
Norwich, , United Kingdom
Queens Medical Centre
Nottingham, , United Kingdom
Salisbury District Hospital
Salisbury, , United Kingdom
University Hospital of North Tees
Stockton-on-Tees, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Kings Mill Hospital
Sutton in Ashfield, , United Kingdom
Manor Hospital
Walsall, , United Kingdom
Royal Albert Edward Infirmary
Wigan, , United Kingdom
New Cross Hosptial
Wolverhampton, , United Kingdom
Worcestershire Royal Hospital
Worcester, , United Kingdom
Wythenshawe Hosptial
Wythenshawe, , United Kingdom
Yeovil District Hospital
Yeovil, , United Kingdom
York Hospital
York, , United Kingdom
Countries
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References
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Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and West Midlands Research Collaborative. Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial. Lancet. 2020 Feb 8;395(10222):417-426. doi: 10.1016/S0140-6736(19)32637-6.
Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and the West Midlands Research Collaborative. Feasibility study from a randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement. Colorectal Dis. 2016 Sep;18(9):889-96. doi: 10.1111/codi.13310.
Related Links
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Trial website
Other Identifiers
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46330337
Identifier Type: REGISTRY
Identifier Source: secondary_id
13461
Identifier Type: REGISTRY
Identifier Source: secondary_id
12/WM/0187
Identifier Type: OTHER
Identifier Source: secondary_id
RG_11-186
Identifier Type: -
Identifier Source: org_study_id
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