Reinforcement of Closure of Stoma Site
- Conditions
- Hernia
- Interventions
- Procedure: Standard ClosureDevice: Strattice™ Reconstructive Tissue Matrix
- Registration Number
- NCT02238964
- Lead Sponsor
- University of Birmingham
- Brief Summary
ROCSS is a randomised controlled trial of the placement of a biological mesh at the site of stoma closure. Our hypothesis is that reinforcing the stoma closure site with a collagen mesh (Strattice®) is superior to the standard technique in preventing herniation at 2 years.
- Detailed Description
Closure of complex and contaminated abdominal wounds is challenging and carries risks, including wound dehiscence and incisional hernias. Use of biological meshes in these situations may provide a safe method of reducing these complications, especially long-term incisional hernias. ROCSS will use stoma site closure as a model for biological mesh placement during any difficult contaminated abdominal wall closures.
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%).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 790
- Require an elective closure of an ileostomy or a colostomy.
- Able and willing to provide written informed consent.
- Aged 18 years or over.
- Taking part in another clinical study which is related to the surgical procedure.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard closure 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. Strattice™ Reconstructive Tissue Matrix 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).
- Primary Outcome Measures
Name Time Method Rate of clinically detectable hernias at two years post-randomisation. Two years post-randomisation.
- Secondary Outcome Measures
Name Time Method Pain assessed using a 100 point visual analogue scale at baseline, 30 days postoperatively, 12 and 24 months post-randomisation. Baseline, 30 days post-operatively, one and two years post-randomisation Surgical complications, including wound infections and seroma formation, at 30 days postoperatively and at 1 year post-randomisation. 30 days postoperatively, 1 year post randomisation Costs per hernia clinically detected at 2 years post-randomisation. Two years post-randomisation. Radiological hernia rate at one year post-randomisation. One year post-randomisation. An exploratory analysis will also 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.
Surgical re-intervention rates at 2 years post-randomisation. Two years post-randomisation. Quality of life assessed using EuroQol EQ-5D at baseline, 30 days post-operatively, 12 and 24 months post-randomisation. Baseline, 30 days post-operatively, one and two years post-randomisation Two-year and long-term costs per additional quality adjusted life (QALY) year gained. Two-year post-randomisation Incidence of developing a symptomatic hernia evaluated at 12 and 24 months postrandomisation. One and two years post-randomisation. The clinical detection of hernias defined by palpable fascial defects, and global weaknesses around closed stoma sites without palpable fascial defects, will be recorded. Patient-reported hernia symptoms including a local lump or pain at the site of the stoma closure will also be collected.
Trial Locations
- Locations (35)
Hvidovre Hospital
🇩🇰Copenhagen, Denmark
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Heart of England NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Sandwell General Hospital
🇬🇧Birmingham, United Kingdom
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
Broomfield Hospital
🇬🇧Chelmsford, United Kingdom
Chesterfield Royal Hospital
🇬🇧Chesterfield, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Western Sussex Hospitals NHS Foundation Trust
🇬🇧Chichester, United Kingdom
Doncaster Royal Infirmary
🇬🇧Doncaster, United Kingdom
Dorset Country Hospital
🇬🇧Dorchester, United Kingdom
James Paget University Hospital
🇬🇧Great Yarmouth, 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
Tameside General Hospital
🇬🇧Ashton-under-Lyne, United Kingdom
St Peters Hospital
🇬🇧Chertsey, United Kingdom
Royal United Hospital Bath
🇬🇧Bath, United Kingdom
Pilgrim Hospital
🇬🇧Boston, United Kingdom
St Marks Hospital
🇬🇧Harrow, United Kingdom
Raigmore Hospital
🇬🇧Inverness, United Kingdom