Reinforcement of Closure of Stoma Site (ROCSS)
Hernia
About this trial
This is an interventional prevention trial for Hernia
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.
Sites / Locations
- Hvidovre Hospital
- Academisch Medisch Centrum
- Tameside General Hospital
- Royal United Hospital Bath
- Heart of England NHS Foundation Trust
- Queen Elizabeth Hospital
- Sandwell General Hospital
- Pilgrim Hospital
- Bristol Royal Infirmary
- Broomfield Hospital
- St Peters Hospital
- Chesterfield Royal Hospital
- Western Sussex Hospitals NHS Foundation Trust
- University Hospital Coventry
- Doncaster Royal Infirmary
- Dorset Country Hospital
- James Paget University Hospital
- St Marks Hospital
- Raigmore Hospital
- University Hospitals of Leicester NHS Trust
- Macclesfield District General Hospital
- Queen Elizabeth the Queen Mother Hospital
- Norfolk & Norwich University Hospital
- Queens Medical Centre
- Salisbury District Hospital
- University Hospital of North Tees
- Royal Stoke University Hospital
- Kings Mill Hospital
- Manor Hospital
- Royal Albert Edward Infirmary
- New Cross Hosptial
- Worcestershire Royal Hospital
- Wythenshawe Hosptial
- Yeovil District Hospital
- York Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Strattice™ Reconstructive Tissue Matrix
Standard closure
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).
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.