<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/NCT02973009</url>
  </required_header>
  <id_info>
    <org_study_id>PI2016_843_0031</org_study_id>
    <nct_id>NCT02973009</nct_id>
  </id_info>
  <brief_title>Impact of the Systematic Closure of the Epigastric Trocar on Postoperative Incisional Hernia After Sleeve Gastrectomy Rate of First Intention. Monocentric Study, Before / After Prospective.</brief_title>
  <acronym>TROCSLEEVE</acronym>
  <official_title>Impact of the Systematic Closure of the Epigastric Trocar on Postoperative Incisional Hernia After Sleeve Gastrectomy Rate of First Intention. Monocentric Study, Before / After Prospective.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</source>
  <brief_summary>
    <textblock>
      The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic&#xD;
      booming in recent years.&#xD;
&#xD;
      This is an effective intervention on weight loss over the long term with few early&#xD;
      postoperative complications and low morbidity in the long term.&#xD;
&#xD;
      Obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a&#xD;
      relative risk of 29% in connection with cholecystectomy.&#xD;
&#xD;
      Several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical&#xD;
      evaluation.&#xD;
&#xD;
      Recently, it was shown eventrations rate between 26 and 38% under the Roux-en-Y gastric&#xD;
      bypass with a rupture rate increased on epigastric trocar. The assessment in the context of&#xD;
      this series was ultrasound.&#xD;
&#xD;
      Recent data suggest that the absence of closure of the epigastric trocar of 12mm through an&#xD;
      SG of first intention was associated with a hernia rate of 17% with a scannographic&#xD;
      evaluation.&#xD;
&#xD;
      Also, recently, Tabone suggests that the systematic closure of the epigastric trocar site&#xD;
      would not be as effective as lateralize inserting the trocar from the white line of the&#xD;
      abdomen. Change the positioning of this trocar induce an additional difficulty in handling&#xD;
      instruments for the realization of the SG with an désaxassion instruments, a conflict between&#xD;
      the instruments for the realization of the SG and the optical laparoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    investigator choice&#xD;
  </why_stopped>
  <start_date type="Actual">May 16, 2017</start_date>
  <completion_date type="Actual">May 16, 2017</completion_date>
  <primary_completion_date type="Actual">May 16, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>systematic closure of the epigastric trocar</measure>
    <time_frame>1 year</time_frame>
    <description>Test the hypothesis that the systematic closure of the epigastric trocar 12 mm would reduce by three the number of rupture on epigastric trocar after SG first intent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of incisional hernia.</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate the rate of incisional hernia at 1 year after 1st SG intention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of rupture opposite</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate the rate of rupture opposite the closure of the open laparoscopy incision closed using the conventional technique (Deguines JB, Qassemyar Q Dhahri A Brehant O, Fuks D Verhaeghe P Regimbeau JM. Technique of open laparoscopy .. for supramesocolic surgery in obese patients Surg Endosc 2010 Aug; 24 (8): 2053-5) from the rupture rate over the epigastric port with the use of WECK EFx ™ (Teleflex Medical SAS, F-31460 the Faget, France).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>1 year</time_frame>
    <description>Morbidity related to the closing act of the epigastric trocar (organ wound, local hematoma, surgical site infection).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of the closure of the epigastric trocar.</measure>
    <time_frame>during surgery</time_frame>
    <description>Evaluation of the duration of the closure of the epigastric trocar.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of the implementation of the device</measure>
    <time_frame>1 year</time_frame>
    <description>Analysis of the evolution of the duration of the implementation of the device</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Bariatric Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        major patients who underwent SG 1st intention by laparoscopy as part of the surgical&#xD;
        management of obesity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  major patients (≥ 18 years) who underwent SG 1st intention by laparoscopy as part of&#xD;
             the surgical management of obesity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  antecedent of previous gastric band.&#xD;
&#xD;
          -  History of SG (repeat-SG).&#xD;
&#xD;
          -  median laparotomy history or subcostal right.&#xD;
&#xD;
          -  SG performed as an ambulatory surgery.&#xD;
&#xD;
          -  Patients with early postoperative complications (≤ J90) specific to the SG&#xD;
             (postoperative gastric fistula, postoperative bleeding, hematoma or postoperative&#xD;
             intra-abdominal abscess)&#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>Jean-Marc REGIMBEAU, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU amiens-Picardie</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>The Sleeve Gastrectomy (SG)</keyword>
  <keyword>bariatric surgery</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>systematic closure of the epigastric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Incisional 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/NCT02973009
org study id: PI2016_843_0031
nct id: NCT02973009
lead sponsor: 
The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic
      booming in recent years.

      This is an effective intervention on weight loss over the long term with few early
      postoperative complications and low morbidity in the long term.

      Obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a
      relative risk of 29% in connection with cholecystectomy.

      Several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical
      evaluation.

      Recently, it was shown eventrations rate between 26 and 38% under the Roux-en-Y gastric
      bypass with a rupture rate increased on epigastric trocar. The assessment in the context of
      this series was ultrasound.

      Recent data suggest that the absence of closure of the epigastric trocar of 12mm through an
      SG of first intention was associated with a hernia rate of 17% with a scannographic
      evaluation.

      Also, recently, Tabone suggests that the systematic closure of the epigastric trocar site
      would not be as effective as lateralize inserting the trocar from the white line of the
      abdomen. Change the positioning of this trocar induce an additional difficulty in handling
      instruments for the realization of the SG with an désaxassion instruments, a conflict between
      the instruments for the realization of the SG and the optical laparoscopy.
observational model: Cohort
time perspective: Prospective
measure: systematic closure of the epigastric trocar
time frame: 1 year
description: Test the hypothesis that the systematic closure of the epigastric trocar 12 mm would reduce by three the number of rupture on epigastric trocar after SG first intent
measure: rate of incisional hernia.
time frame: 1 year
description: Evaluate the rate of incisional hernia at 1 year after 1st SG intention.
measure: rate of rupture opposite
time frame: 1 year
description: To evaluate the rate of rupture opposite the closure of the open laparoscopy incision closed using the conventional technique (Deguines JB, Qassemyar Q Dhahri A Brehant O, Fuks D Verhaeghe P Regimbeau JM. Technique of open laparoscopy .. for supramesocolic surgery in obese patients Surg Endosc 2010 Aug; 24 (8): 2053-5) from the rupture rate over the epigastric port with the use of WECK EFx ™ (Teleflex Medical SAS, F-31460 the Faget, France).
measure: Morbidity
time frame: 1 year
description: Morbidity related to the closing act of the epigastric trocar (organ wound, local hematoma, surgical site infection).
measure: duration of the closure of the epigastric trocar.
time frame: during surgery
description: Evaluation of the duration of the closure of the epigastric trocar.
measure: duration of the implementation of the device
time frame: 1 year
description: Analysis of the evolution of the duration of the implementation of the device
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Marc REGIMBEAU, professor
role: Principal Investigator
affiliation: CHU amiens-Picardie
responsible party type: Sponsor
mesh term: Incisional Hernia