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ISRCTN
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ISRCTN46330337
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DOI
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10.1186/ISRCTN46330337
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised controlled trial of Reinforcement Of Closure of Stoma Site using a biological mesh
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Scientific title
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Acronym
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ROCSS
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Serial number at source
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13461
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Study hypothesis
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Abdominal wall hernias are common and are a significant cause of morbidity. Incisional hernias form following closure of the abdominal wall musculature. Incisional hernias at the site of stoma closure are not an infrequent problem, occurring in up to 30% of cases. Not only are they associated with adverse effects on patient’s quality of life but in up to 10 % of cases, patients require complex reoperation associated with a high complication rate. It is for this reason that many patients choose to live with the hernia rather than undergo further surgery. Techniques that prevent the hernia from developing would improve the patient’s quality of life and reduce the costs associated with redo surgery. Repair of incisional hernia commonly employs prosthetic meshes that reinforce and aid the tissue healing process. It is inappropriate to use synthetic mesh at site of previous stomas as there has been leakage of bowel contents that would infect the mesh and further compound the healing process. Many surgeons therefore choose to close the defect with sutures rather than using mesh. This may be a contributory factor in the subsequent development of hernias. Biological mesh implants may be more suitable in these circumstances.
There is no evidence regarding the benefits of using biological mesh to prevent hernias at site of stoma closure. The balance of risks and benefits has not been reliably assessed in a randomised control trial. ROCCS 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.
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13461
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Lay summary
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Not provided at time of registration
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Ethics approval
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12/WM/0187
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes; Subtopic: Oral and Gastrointestinal (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Gastrointestinal, Surgery
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Participants - inclusion criteria
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Patients to be included in the study must:
1. Require an elective closure of stoma site
2. Have given written informed consent
3. Male & Female, be aged 18 or over
4. Agree to the randomised procedure
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Participants - exclusion criteria
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1.Patients taking part in another clinical study which directly relates to the surgical procedure
2. Allergic to any porcine or collagen products
3. Unable or unwilling to provide written informed consent
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Anticipated start date
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29/10/2012
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Anticipated end date
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29/10/2013
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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Planned Sample Size: 90; UK Sample Size: 90
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Interventions
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Reinforcement by collagen mesh: Reinforcement of the stoma closure site using the Strattice® collagen mesh.
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Primary outcome measure(s)
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Recruitment at 12 months
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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LifeCell Corporation (USA)
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Trial website
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Publications
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Contact name
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Prof
Dion
Morton
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Address
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Academic Department of Surgery
School of Medicine
Queen Elizabeth Hospital
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TH
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Country
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United Kingdom
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Email
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dion.morton@uhb.nhs.uk
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Sponsor
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University of Birmingham (UK)
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Address
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Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Sponsor website:
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http://www.birmingham.ac.uk
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Date applied
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28/11/2012
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Last edited
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30/11/2012
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Date ISRCTN assigned
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30/11/2012
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