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Reinforcement of Closure of Stoma Site (ROCSS)

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ClinicalTrials.gov Identifier: NCT02238964
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
LifeCell
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hernia Device: Strattice™ Reconstructive Tissue Matrix Procedure: Standard Closure Phase 2 Phase 3

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%).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 790 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Reinforcement of Closure of Stoma Site Using a Biological Mesh.
Actual Study Start Date : November 2012
Actual Primary Completion Date : November 2017
Actual Study Completion Date : May 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: 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).
Device: 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.

Active Comparator: 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.

Procedure: 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.




Primary Outcome Measures :
  1. Rate of clinically detectable hernias at two years post-randomisation. [ Time Frame: Two years post-randomisation. ]

Secondary Outcome Measures :
  1. Radiological hernia rate at one year post-randomisation. [ Time Frame: 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.

  2. Incidence of developing a symptomatic hernia evaluated at 12 and 24 months postrandomisation. [ Time Frame: 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.

  3. Surgical re-intervention rates at 2 years post-randomisation. [ Time Frame: Two years post-randomisation. ]
  4. Surgical complications, including wound infections and seroma formation, at 30 days postoperatively and at 1 year post-randomisation. [ Time Frame: 30 days postoperatively, 1 year post randomisation ]
  5. Quality of life assessed using EuroQol EQ-5D at baseline, 30 days post-operatively, 12 and 24 months post-randomisation. [ Time Frame: Baseline, 30 days post-operatively, one and two years post-randomisation ]
  6. Pain assessed using a 100 point visual analogue scale at baseline, 30 days postoperatively, 12 and 24 months post-randomisation. [ Time Frame: Baseline, 30 days post-operatively, one and two years post-randomisation ]
  7. Costs per hernia clinically detected at 2 years post-randomisation. [ Time Frame: Two years post-randomisation. ]
  8. Two-year and long-term costs per additional quality adjusted life (QALY) year gained. [ Time Frame: Two-year post-randomisation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238964


Locations
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Denmark
Hvidovre Hospital
Copenhagen, Denmark
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands
United Kingdom
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
Sponsors and Collaborators
University of Birmingham
LifeCell
Investigators
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Principal Investigator: Dion G Morton, MD Professor of Colorectal Surgery

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT02238964     History of Changes
Other Study ID Numbers: RG_11-186
46330337 ( Registry Identifier: ISRCTN )
13461 ( Registry Identifier: UKCRN )
12/WM/0187 ( Other Identifier: NRES )
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical