<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/NCT01722565</url>
  </required_header>
  <id_info>
    <org_study_id>LAP-APR-2012-028</org_study_id>
    <nct_id>NCT01722565</nct_id>
  </id_info>
  <brief_title>Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection</brief_title>
  <official_title>Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the&#xD;
      many prevention and treatment techniques that have been described. Since the introduction of&#xD;
      laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia&#xD;
      remains a surgical problem of considerable importance, requiring significant consumption of&#xD;
      public health and economic resources, and representing a major alteration of the quality of&#xD;
      life of these patients.&#xD;
&#xD;
      Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in&#xD;
      elective surgery for laparoscopic abdominoperineal resection.&#xD;
&#xD;
      Methodology: prospective, multidisciplinary, multi-center randomized controlled study.&#xD;
      Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal&#xD;
      resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic&#xD;
      abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25).&#xD;
      Sample size was calculated based on a proportion of parastomal hernia of 65% in the control&#xD;
      group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are&#xD;
      required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32&#xD;
      patients. The efficacy will be evaluated clinically at six months and abdominal CT will be&#xD;
      performed at 12 months along with another clinical evaluation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The reduction in the incidence of Parastomal Hernia after the mesh placement</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Parastomal Hernia</condition>
  <arm_group>
    <arm_group_label>Mesh Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving conventional sigmoid end colostomy plus a preperitoneal lightweight mesh Physiomesh® by laparoscopic procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients receiving conventional sigmoid end colostomy by laparoscopic procedure, without mesh</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)</intervention_name>
    <arm_group_label>Mesh Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of either sex intervened electively for colorectal surgery (rectal cancer) in&#xD;
             whom definitive colostomy is indicated after laparoscopic abdominoperineal amputation.&#xD;
&#xD;
          -  Life expectancy above 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Patients with allergy or intolerance of the compounds in the mesh&#xD;
&#xD;
          -  Carriers of prosthetic meshes in the area of the ostomy&#xD;
&#xD;
          -  Patients electively intervened for colorectal surgery (neo de reco) in whom definitive&#xD;
             colostomy is indicated after abdominoperineal amputation but not via a laparoscopic&#xD;
             approach.&#xD;
&#xD;
          -  Cirrhotic patients&#xD;
&#xD;
          -  Patients with life expectancy below 12 months due to underlying disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier Serra-Aracil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporacion Sanitaria Universitaria Parc Tauli</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manuel Lopez-Cano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Vall d'Hebron</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corporacion Sanitaria Universitaria Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>September 9, 2015</last_update_submitted>
  <last_update_submitted_qc>September 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Xavier Serra-Aracil</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Parastomal hernias</keyword>
  <keyword>Tolerance of lightweight meshes</keyword>
  <keyword>laparoscopic abdominoperineal resection</keyword>
  <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/NCT01722565
org study id: LAP-APR-2012-028
nct id: NCT01722565
lead sponsor: 
has dmc: No
Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the
      many prevention and treatment techniques that have been described. Since the introduction of
      laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia
      remains a surgical problem of considerable importance, requiring significant consumption of
      public health and economic resources, and representing a major alteration of the quality of
      life of these patients.

      Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in
      elective surgery for laparoscopic abdominoperineal resection.

      Methodology: prospective, multidisciplinary, multi-center randomized controlled study.
      Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal
      resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic
      abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25).
      Sample size was calculated based on a proportion of parastomal hernia of 65% in the control
      group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are
      required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32
      patients. The efficacy will be evaluated clinically at six months and abdominal CT will be
      performed at 12 months along with another clinical evaluation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The reduction in the incidence of Parastomal Hernia after the mesh placement
time frame: 12 months
arm group label: Mesh Group
arm group type: Experimental
description: Patients receiving conventional sigmoid end colostomy plus a preperitoneal lightweight mesh Physiomesh® by laparoscopic procedure
arm group label: Control Group
arm group type: No Intervention
description: Patients receiving conventional sigmoid end colostomy by laparoscopic procedure, without mesh
intervention type: Procedure
intervention name: laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)
arm group label: Mesh Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Xavier Serra-Aracil, MD
role: Principal Investigator
affiliation: Corporacion Sanitaria Universitaria Parc Tauli
last name: Manuel Lopez-Cano, MD
role: Principal Investigator
affiliation: Hospital Vall d'Hebron
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Xavier Serra-Aracil
investigator title: Medical Doctor
mesh term: Hernia