Clinical trial NCT02238964: Reinforcement of Closure of Stoma Site
Official title: A Randomised Controlled Trial of Reinforcement of Closure of Stoma Site Using a Biological Mesh.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hernia
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: LifeCell
First posted: 2014-09-12
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%).

Eligibility criteria: Inclusion Criteria:

* Require an elective closure of an ileostomy or a colostomy.
* Able and willing to provide written informed consent.
* Aged 18 years or over.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of clinically detectable hernias at two years post-randomisation.
timeFrame: Two years post-randomisation.
Secondary outcomes:
measure: Radiological hernia rate at one year post-randomisation.
timeFrame: One year post-randomisation.
measure: Incidence of developing a symptomatic hernia evaluated at 12 and 24 months postrandomisation.
timeFrame: One and two years post-randomisation.
measure: Surgical re-intervention rates at 2 years post-randomisation.
timeFrame: Two years post-randomisation.
measure: Surgical complications, including wound infections and seroma formation, at 30 days postoperatively and at 1 year post-randomisation.
timeFrame: 30 days postoperatively, 1 year post randomisation
measure: Quality of life assessed using EuroQol EQ-5D at baseline, 30 days post-operatively, 12 and 24 months post-randomisation.
timeFrame: Baseline, 30 days post-operatively, one and two years post-randomisation
measure: Pain assessed using a 100 point visual analogue scale at baseline, 30 days postoperatively, 12 and 24 months post-randomisation.
timeFrame: Baseline, 30 days post-operatively, one and two years post-randomisation
measure: Costs per hernia clinically detected at 2 years post-randomisation.
timeFrame: Two years post-randomisation.
measure: Two-year and long-term costs per additional quality adjusted life (QALY) year gained.
timeFrame: Two-year post-randomisation
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Ashton-under-Lyne
country: United Kingdom
facility: Tameside General Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Birmingham
country: United Kingdom
facility: Sandwell General Hospital
city: Boston
country: United Kingdom
facility: Pilgrim Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
city: Chertsey
country: United Kingdom
facility: St Peters Hospital
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospital
city: Chichester
country: United Kingdom
facility: Western Sussex Hospitals NHS Foundation Trust
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
city: Dorchester
country: United Kingdom
facility: Dorset Country Hospital
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospital
city: Harrow
country: United Kingdom
facility: St Marks Hospital
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
city: Margate
country: United Kingdom
facility: Queen Elizabeth the Queen Mother Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
city: Stockton-on-Tees
country: United Kingdom
facility: University Hospital of North Tees
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Sutton in Ashfield
country: United Kingdom
facility: Kings Mill Hospital
city: Walsall
country: United Kingdom
facility: Manor Hospital
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary
city: Wolverhampton
country: United Kingdom
facility: New Cross Hosptial
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
city: Wythenshawe
country: United Kingdom
facility: Wythenshawe Hosptial
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
city: York
country: United Kingdom
facility: York Hospital
Study officials:
affiliation: Professor of Colorectal Surgery
name: Dion G Morton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.