<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02238964</url>
  </required_header>
  <id_info>
    <org_study_id>RG_11-186</org_study_id>
    <secondary_id>46330337</secondary_id>
    <secondary_id>13461</secondary_id>
    <secondary_id>12/WM/0187</secondary_id>
    <nct_id>NCT02238964</nct_id>
  </id_info>
  <brief_title>Reinforcement of Closure of Stoma Site</brief_title>
  <acronym>ROCSS</acronym>
  <official_title>A Randomised Controlled Trial of Reinforcement of Closure of Stoma Site Using a Biological Mesh.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LifeCell</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      ROCSS is a randomised controlled trial of the placement of a biological mesh at the site of&#xD;
      stoma closure. Our hypothesis is that reinforcing the stoma closure site with a collagen mesh&#xD;
      (Strattice®) is superior to the standard technique in preventing herniation at 2 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Closure of complex and contaminated abdominal wounds is challenging and carries risks,&#xD;
      including wound dehiscence and incisional hernias. Use of biological meshes in these&#xD;
      situations may provide a safe method of reducing these complications, especially long-term&#xD;
      incisional hernias. ROCSS will use stoma site closure as a model for biological mesh&#xD;
      placement during any difficult contaminated abdominal wall closures.&#xD;
&#xD;
      Hernia at the site of stoma closure occurs in up to 30% of patients and is associated with&#xD;
      adverse effects on quality of life. In up to 10% of cases, patients are submitted to complex&#xD;
      re-operation which carries significant morbidity. Not all patients will report symptoms or&#xD;
      undergo repair, as they do not wish to have a further major operation. Incisional hernias at&#xD;
      the site of stomas closure form an important and well defined subgroup. If there is a&#xD;
      measurable benefit from mesh insertion, elective use of a collagen mesh would warrant&#xD;
      consideration in the closure of other difficult, contaminated abdominal wounds. This study&#xD;
      will also provide useful information on the value of using a CT scan as an early diagnostic&#xD;
      tool of herniation, which could then be used in future abdominal wall studies as a surrogate&#xD;
      endpoint for clinical hernia.&#xD;
&#xD;
      ROCSS aims to assess whether a biological mesh (collagen tissue matrix) reduces the incidence&#xD;
      of clinically detectable stoma closure site hernias at two years compared to standard closure&#xD;
      techniques. The primary outcome is Occurrence of clinically detectable hernias at two years&#xD;
      post randomisation. Other outcomes include surgical re-intervention rate, surgical&#xD;
      complications at 30 days post-operation and 1 year post-randomisation, quality of life and&#xD;
      post-operative pain, cost-benefit analysis and radiological hernia rate at one year&#xD;
      post-randomisation (an exploratory analysis will compare radiological hernia rate at 1 year&#xD;
      with clinical hernia rate at 2 years to assess the value of using a CT scan as an early&#xD;
      diagnostic tool of incisional hernias).&#xD;
&#xD;
      Randomisation is 1:1 between Strattice® mesh vs. standard closure. The sample size for the&#xD;
      trial is 560 (80% power, 10% dropout/crossover, 40% proportional reduction - 25% to 15%) and&#xD;
      recruitment will be over 2 years from at least 30 centres. ROCSS will be a double blind&#xD;
      (observer blind) randomised controlled trial with a CT scan at one year and clinical follow&#xD;
      up at 2 years. Cost benefit analysis and quality of life analysis will be performed at 2&#xD;
      years. The sample size will be reviewed prior to reaching target and may be increased 790&#xD;
      (90% power, 20% dropout/crossover, 40% proportional reduction - 25% to 15%).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">May 18, 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of clinically detectable hernias at two years post-randomisation.</measure>
    <time_frame>Two years post-randomisation.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiological hernia rate at one year post-randomisation.</measure>
    <time_frame>One year post-randomisation.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of developing a symptomatic hernia evaluated at 12 and 24 months postrandomisation.</measure>
    <time_frame>One and two years post-randomisation.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical re-intervention rates at 2 years post-randomisation.</measure>
    <time_frame>Two years post-randomisation.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical complications, including wound infections and seroma formation, at 30 days postoperatively and at 1 year post-randomisation.</measure>
    <time_frame>30 days postoperatively, 1 year post randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed using EuroQol EQ-5D at baseline, 30 days post-operatively, 12 and 24 months post-randomisation.</measure>
    <time_frame>Baseline, 30 days post-operatively, one and two years post-randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed using a 100 point visual analogue scale at baseline, 30 days postoperatively, 12 and 24 months post-randomisation.</measure>
    <time_frame>Baseline, 30 days post-operatively, one and two years post-randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs per hernia clinically detected at 2 years post-randomisation.</measure>
    <time_frame>Two years post-randomisation.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Two-year and long-term costs per additional quality adjusted life (QALY) year gained.</measure>
    <time_frame>Two-year post-randomisation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">790</enrollment>
  <condition>Hernia</condition>
  <arm_group>
    <arm_group_label>Strattice™ Reconstructive Tissue Matrix</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
Closure of the muscle, soft tissues and skin is up to the discretion of the operating surgeon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Strattice™ Reconstructive Tissue Matrix</intervention_name>
    <description>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.</description>
    <arm_group_label>Strattice™ Reconstructive Tissue Matrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Closure</intervention_name>
    <description>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.</description>
    <arm_group_label>Standard closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Require an elective closure of an ileostomy or a colostomy.&#xD;
&#xD;
          -  Able and willing to provide written informed consent.&#xD;
&#xD;
          -  Aged 18 years or over.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking part in another clinical study which is related to the surgical procedure.&#xD;
&#xD;
          -  Allergic to any porcine or collagen products.&#xD;
&#xD;
          -  History of familial adenomatous polyposis, due to increased risk of desmoid tumours.&#xD;
&#xD;
          -  The surgeon determines that a mesh repair will definitely be required e.g. due to&#xD;
             large parastomal hernia.&#xD;
&#xD;
          -  Unable or unwilling to provide written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dion G Morton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Colorectal Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hvidovre Hospital</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tameside General Hospital</name>
      <address>
        <city>Ashton-under-Lyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal United Hospital Bath</name>
      <address>
        <city>Bath</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart of England NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sandwell General Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pilgrim Hospital</name>
      <address>
        <city>Boston</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Infirmary</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broomfield Hospital</name>
      <address>
        <city>Chelmsford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Peters Hospital</name>
      <address>
        <city>Chertsey</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesterfield Royal Hospital</name>
      <address>
        <city>Chesterfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Sussex Hospitals NHS Foundation Trust</name>
      <address>
        <city>Chichester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Coventry</name>
      <address>
        <city>Coventry</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doncaster Royal Infirmary</name>
      <address>
        <city>Doncaster</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dorset Country Hospital</name>
      <address>
        <city>Dorchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Paget University Hospital</name>
      <address>
        <city>Great Yarmouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Marks Hospital</name>
      <address>
        <city>Harrow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raigmore Hospital</name>
      <address>
        <city>Inverness</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Leicester NHS Trust</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macclesfield District General Hospital</name>
      <address>
        <city>Macclesfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth the Queen Mother Hospital</name>
      <address>
        <city>Margate</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk &amp; Norwich University Hospital</name>
      <address>
        <city>Norwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salisbury District Hospital</name>
      <address>
        <city>Salisbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Tees</name>
      <address>
        <city>Stockton-on-Tees</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Stoke University Hospital</name>
      <address>
        <city>Stoke-on-Trent</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings Mill Hospital</name>
      <address>
        <city>Sutton in Ashfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manor Hospital</name>
      <address>
        <city>Walsall</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Albert Edward Infirmary</name>
      <address>
        <city>Wigan</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hosptial</name>
      <address>
        <city>Wolverhampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Worcestershire Royal Hospital</name>
      <address>
        <city>Worcester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wythenshawe Hosptial</name>
      <address>
        <city>Wythenshawe</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeovil District Hospital</name>
      <address>
        <city>Yeovil</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Hospital</name>
      <address>
        <city>York</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.birmingham.ac.uk/ROCSS</url>
    <description>Trial website</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02238964
org study id: RG_11-186
secondary id: 46330337
secondary id: 13461
secondary id: 12/WM/0187
nct id: NCT02238964
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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%).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Rate of clinically detectable hernias at two years post-randomisation.
time frame: Two years post-randomisation.
measure: Radiological hernia rate at one year post-randomisation.
time frame: One year post-randomisation.
description: 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.
measure: Incidence of developing a symptomatic hernia evaluated at 12 and 24 months postrandomisation.
time frame: One and two years post-randomisation.
description: 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.
measure: Surgical re-intervention rates at 2 years post-randomisation.
time frame: Two years post-randomisation.
measure: 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
measure: 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
measure: 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
measure: Costs per hernia clinically detected at 2 years post-randomisation.
time frame: Two years post-randomisation.
measure: Two-year and long-term costs per additional quality adjusted life (QALY) year gained.
time frame: Two-year post-randomisation
arm group label: Strattice™ Reconstructive Tissue Matrix
arm group type: Active Comparator
description: 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).
arm group label: Standard closure
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: Strattice™ Reconstructive Tissue Matrix
description: 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.
arm group label: Strattice™ Reconstructive Tissue Matrix
intervention type: Procedure
intervention name: Standard Closure
description: 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.
arm group label: Standard closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dion G Morton, MD
role: Principal Investigator
affiliation: Professor of Colorectal Surgery
facility: 
facility: 
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country: Denmark
country: Netherlands
country: United Kingdom
url: http://www.birmingham.ac.uk/ROCSS
description: Trial website
responsible party type: Sponsor
mesh term: Hernia