<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/NCT03255239</url>
  </required_header>
  <id_info>
    <org_study_id>Abdominal wall hernia repair</org_study_id>
    <nct_id>NCT03255239</nct_id>
  </id_info>
  <brief_title>Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias</brief_title>
  <official_title>Randomized Clinical Trial Comparing Open Preperitoneal Mesh, Retromuscular Mesh and Suture Repair for Abdominal Wall Hernias Less Than 3 cm Diameter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Universitaire Taher Sfar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Universitaire Taher Sfar</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture&#xD;
      repair for ventral hernias less than 3 cm diameter&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many techniques of ventral hernias repair have been reported. It is shown that open mesh&#xD;
      hernia repairs have low recurrence and low complication rates then suture repair. But for&#xD;
      hernias less than 3 cm some surgeons defend the treatment by suture. The main variable of&#xD;
      interest is the location of mesh placement compared to suture repair. The investigator will&#xD;
      compare in a prospective randomized clinical trial three techniques of abdominal wall hernia&#xD;
      repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias&#xD;
      less than 3 cm. All patients underwent general anesthesia. The investigators used&#xD;
      Polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in&#xD;
      animal models. Operative notes were physician-abstracted and the presence, type, and location&#xD;
      of mesh prosthesis was recorded. Independent variables of interest were patient-level&#xD;
      demographics (age and sex), facility where hernia repair occurred, year of hernia repair,&#xD;
      preoperative comorbid conditions, history of prior repair, and intraoperative variables. The&#xD;
      results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10)&#xD;
      on the day of the first outpatient visit, operating time evaluated as skin-to-skin time,&#xD;
      drain management and both of early and late complications including seroma and hematoma&#xD;
      formation, wound infection, fistula formation and recurrence rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence rates</measure>
    <time_frame>One year</time_frame>
    <description>Late complications of ventral hernia repair</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operating time</measure>
    <time_frame>15 to 90 minutes</time_frame>
    <description>operating time evaluated as skin-to-skin time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early complication</measure>
    <time_frame>30 days</time_frame>
    <description>Early complicaion including seroma and hematoma formation, wound infection and fistula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>6, 12 and 24 hours</time_frame>
    <description>Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Ventral Hernia</condition>
  <condition>Ventral Incisional Hernia</condition>
  <condition>Umbilical Hernia</condition>
  <arm_group>
    <arm_group_label>Preperitoneal mesh repair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ventral hernia repair using polyester preperitoneal mesh repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retromuscular mesh repair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ventral hernia repair using polyester retromuscular mesh repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suture repair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ventral hernia repair using suture repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ventral hernia repair</intervention_name>
    <description>Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.</description>
    <arm_group_label>Preperitoneal mesh repair</arm_group_label>
    <arm_group_label>Retromuscular mesh repair</arm_group_label>
    <arm_group_label>Suture repair</arm_group_label>
    <other_name>retromuscular mesh repair</other_name>
    <other_name>preperitoneal mesh repair</other_name>
    <other_name>suture hernia repair</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Vebtral hernia or post incisional hernia diameter &lt; 3 cm&#xD;
&#xD;
          -  Male or female aged between 18 and 90 year-old&#xD;
&#xD;
          -  Elective surgery for ventral hernia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication to the prosthetic treatment.&#xD;
&#xD;
          -  Any hernia or incisional hernia with a collar strictly greater than 3 cm.&#xD;
&#xD;
          -  Previous hernia mesh repaired&#xD;
&#xD;
          -  contraindication for general anaesthesia&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Moez Boudokhane, MD</last_name>
    <phone>98461511</phone>
    <phone_ext>+216</phone_ext>
    <email>Moez-chir@yahoo.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed Ali Chaouch, RD</last_name>
    <phone>26205105</phone>
    <phone_ext>+216</phone_ext>
    <email>Docmedalichaouch@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Taher Sfar Hospital</name>
      <address>
        <city>Mahdia</city>
        <zip>5100</zip>
        <country>Tunisia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CHAOUCH RD Mohamed Ali, Resident</last_name>
      <phone>+21626205105</phone>
      <phone_ext>5070</phone_ext>
      <email>Docmedalichaouch@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Universitaire Taher Sfar</investigator_affiliation>
    <investigator_full_name>Mohamed Ali Chaouch</investigator_full_name>
    <investigator_title>Resident of general surgery</investigator_title>
  </responsible_party>
  <keyword>ventral hernia</keyword>
  <keyword>Open mesh repair</keyword>
  <keyword>Polyester mesh</keyword>
  <keyword>Preperitoneal</keyword>
  <keyword>Retromuscular</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia, Umbilical</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
    <mesh_term>Incisional Hernia</mesh_term>
    <mesh_term>Hernia, Abdominal</mesh_term>
    <mesh_term>Internal Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03255239
org study id: Abdominal wall hernia repair
nct id: NCT03255239
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture
      repair for ventral hernias less than 3 cm diameter
Many techniques of ventral hernias repair have been reported. It is shown that open mesh
      hernia repairs have low recurrence and low complication rates then suture repair. But for
      hernias less than 3 cm some surgeons defend the treatment by suture. The main variable of
      interest is the location of mesh placement compared to suture repair. The investigator will
      compare in a prospective randomized clinical trial three techniques of abdominal wall hernia
      repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias
      less than 3 cm. All patients underwent general anesthesia. The investigators used
      Polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in
      animal models. Operative notes were physician-abstracted and the presence, type, and location
      of mesh prosthesis was recorded. Independent variables of interest were patient-level
      demographics (age and sex), facility where hernia repair occurred, year of hernia repair,
      preoperative comorbid conditions, history of prior repair, and intraoperative variables. The
      results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10)
      on the day of the first outpatient visit, operating time evaluated as skin-to-skin time,
      drain management and both of early and late complications including seroma and hematoma
      formation, wound infection, fistula formation and recurrence rates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence rates
time frame: One year
description: Late complications of ventral hernia repair
measure: Operating time
time frame: 15 to 90 minutes
description: operating time evaluated as skin-to-skin time
measure: Early complication
time frame: 30 days
description: Early complicaion including seroma and hematoma formation, wound infection and fistula
measure: Postoperative pain
time frame: 6, 12 and 24 hours
description: Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit
arm group label: Preperitoneal mesh repair
arm group type: Experimental
description: Ventral hernia repair using polyester preperitoneal mesh repair
arm group label: Retromuscular mesh repair
arm group type: Experimental
description: Ventral hernia repair using polyester retromuscular mesh repair
arm group label: Suture repair
arm group type: Experimental
description: Ventral hernia repair using suture repair
intervention type: Procedure
intervention name: Ventral hernia repair
description: Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.
arm group label: Preperitoneal mesh repair
arm group label: Retromuscular mesh repair
arm group label: Suture repair
other name: retromuscular mesh repair
other name: preperitoneal mesh repair
other name: suture hernia repair
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Moez Boudokhane, MD
phone: 98461511
phone ext: +216
email: Moez-chir@yahoo.fr
last name: Mohamed Ali Chaouch, RD
phone: 26205105
phone ext: +216
email: Docmedalichaouch@gmail.com
facility: 
status: Recruiting
contact: 
country: Tunisia
responsible party type: Principal Investigator
investigator affiliation: Hôpital Universitaire Taher Sfar
investigator full name: Mohamed Ali Chaouch
investigator title: Resident of general surgery
mesh term: Hernia, Umbilical
mesh term: Hernia
mesh term: Hernia, Ventral
mesh term: Incisional Hernia
mesh term: Hernia, Abdominal
mesh term: Internal Hernia
sharing ipd: Undecided