Reinforcement of Closure of Stoma Site

NCT02238964 | Completed Phase 2 DMC

• 4 other identifiers: RG_11-186463303371346112/WM/0187
• Study Type: interventional
• Target: 790
• Locations: 3 countries
• Sites: 35

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.

Conditions

Hernia

Outcome Measures

Primary Outcomes (1)

• Rate of clinically detectable hernias at two years post-randomisation.

  Two years post-randomisation.

Secondary Outcomes (8)

• Radiological hernia rate at one year post-randomisation.

  One year post-randomisation.

• Incidence of developing a symptomatic hernia evaluated at 12 and 24 months postrandomisation.

  One and two years post-randomisation.

• Surgical re-intervention rates at 2 years post-randomisation.

  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

• 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

Study Arms (2)

Strattice™ Reconstructive Tissue Matrix

ACTIVE COMPARATOR

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).

Device: Strattice™ Reconstructive Tissue Matrix

Standard closure

ACTIVE COMPARATOR

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.

Procedure: Standard Closure

Interventions

Strattice™ Reconstructive Tissue Matrix DEVICE

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.

Strattice™ Reconstructive Tissue Matrix

Standard Closure PROCEDURE

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.

Standard closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Birmingham: lead
• LifeCell: collaborator

Study Sites (35)

Hvidovre Hospital

Copenhagen, Denmark

Location

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

Tameside General Hospital

Ashton-under-Lyne, United Kingdom

Location

Royal United Hospital Bath

Bath, United Kingdom

Location

Heart of England NHS Foundation Trust

Birmingham, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Sandwell General Hospital

Birmingham, United Kingdom

Location

Pilgrim Hospital

Boston, United Kingdom

Location

Bristol Royal Infirmary

Bristol, United Kingdom

Location

Broomfield Hospital

Chelmsford, United Kingdom

Location

St Peters Hospital

Chertsey, United Kingdom

Location

Chesterfield Royal Hospital

Chesterfield, United Kingdom

Location

Western Sussex Hospitals NHS Foundation Trust

Chichester, United Kingdom

Location

University Hospital Coventry

Coventry, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, United Kingdom

Location

Dorset Country Hospital

Dorchester, United Kingdom

Location

James Paget University Hospital

Great Yarmouth, United Kingdom

Location

St Marks Hospital

Harrow, United Kingdom

Location

Raigmore Hospital

Inverness, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

Macclesfield District General Hospital

Macclesfield, United Kingdom

Location

Queen Elizabeth the Queen Mother Hospital

Margate, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, United Kingdom

Location

Queens Medical Centre

Nottingham, United Kingdom

Location

Salisbury District Hospital

Salisbury, United Kingdom

Location

University Hospital of North Tees

Stockton-on-Tees, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Location

Kings Mill Hospital

Sutton in Ashfield, United Kingdom

Location

Manor Hospital

Walsall, United Kingdom

Location

Royal Albert Edward Infirmary

Wigan, United Kingdom

Location

New Cross Hosptial

Wolverhampton, United Kingdom

Location

Worcestershire Royal Hospital

Worcester, United Kingdom

Location

Wythenshawe Hosptial

Wythenshawe, United Kingdom

Location

Yeovil District Hospital

Yeovil, United Kingdom

Location

York Hospital

York, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 32035551 DERIVED

• 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.

  PMID: 26924621 DERIVED

Related Links

• Trial website

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dion G Morton, MD

  Professor of Colorectal Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: November 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: May 18, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

NL (1); GB (33); DK (1)