<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/NCT02226887</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)288/2013</org_study_id>
    <nct_id>NCT02226887</nct_id>
  </id_info>
  <brief_title>Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh</brief_title>
  <acronym>ILEOCLOSE</acronym>
  <official_title>&quot;Prospective Randomized Clinical Trial of Ileostomy Closure Site Hernia and it´s Prophylaxis by Placing an Absorbable Mesh &quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Design Prospective , randomized, parallel phase IV.&#xD;
&#xD;
      Objectives Main objective&#xD;
&#xD;
        -  Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of&#xD;
           incisional hernia of the abdominal wall at the site of a loop ileostomy when it is&#xD;
           &quot;closed &quot; to rebuild the intestinal transit. The effectiveness evaluation is done by&#xD;
           tracking with scheduled patient visits for 12 months, assessing the physical examination&#xD;
           the presence or absence of an incisional hernia and an abdominal tomography at the end&#xD;
           of the 12 months .&#xD;
&#xD;
      Secondary objectives Comparison of complications(morbidity and mortality) to assess safety&#xD;
      and tolerability of the placement of the mesh described .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental: Reinforcement with Absorbable Mesh Closure of the ileostomy closure incision is&#xD;
      reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to&#xD;
      the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement&#xD;
      prosthesis (W. L. Gore &amp; Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is&#xD;
      inserted using a &quot;sandwich&quot; method between the edges of the incision and maintained in situ&#xD;
      with a continuous polydioxanone (PDS) suture following a suture length to wound length&#xD;
      (SL:WL) ratio of 4:1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2018</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eventration</measure>
    <time_frame>1 year</time_frame>
    <description>Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occlusive problems</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(&gt;5days),....&#xD;
This is a Clinical measure supported by image if necessary&#xD;
All the morbidity problems are reported independently.&#xD;
1 patient can suffer a prolonged ileus and Anastomotic stenosis and both will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iatrogenic problems</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Damage to structures such as ureters, bowel loops artery / iliac vein ....&#xD;
This is a Surgical and Clinical measure supported by image if necessary.&#xD;
All the morbidity problems are reported independently.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impaired healing</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...&#xD;
This is a Clinical measure always supported by image tests.&#xD;
All the morbidity problems are reported independently.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding problems</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....&#xD;
This is a Clinical measure supported by image if necessary.&#xD;
All the morbidity problems are reported independently.&#xD;
The amount of blood loss won't be specified</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema&#xD;
This is a Clinical measure supported by more specific tests if necessary.&#xD;
All the morbidity problems are reported independently.&#xD;
Cardiologist report will be required for including this items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nephro-urinary complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...&#xD;
This is a Clinical measure supported by more specific tests if necessary.&#xD;
All the morbidity problems are reported independently.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ...&#xD;
This is a Clinical measure always supported by image .&#xD;
All the morbidity problems are reported independently.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular Complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Deep venous thrombosis, phlebitis, thrombophlebitis, ...&#xD;
This is a Clinical measure supported by more specific test if necessary .&#xD;
All the morbidity problems are reported independently</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Liver failure, gastrointestinal bleeding, severe malnutrition, ...&#xD;
This is a Clinical measure supported by blood test and further test if necessary&#xD;
All the morbidity problems are reported independently.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Disorientation, cerebral vascular accident, ...&#xD;
This is a Clinical measure.&#xD;
All the morbidity problems are reported independently.&#xD;
Neurologist report will be required beyond disorientation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local infection</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Superficial, deep, body-cavity&#xD;
This is a Clinical measure supported by image if necessary&#xD;
All the morbidity problems are reported independently</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Hematoma, seroma, evisceration&#xD;
This is a Clinical measure&#xD;
All the morbidity problems are reported independently</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>Days</time_frame>
    <description>Hospital stay since surgery is done</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Loop Ileostomy Closure</condition>
  <arm_group>
    <arm_group_label>MESH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NO MESH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MESH</intervention_name>
    <description>Pre-operative :&#xD;
It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .&#xD;
Surgical technique:&#xD;
Peristomal incision with electrocautery&#xD;
Release the handle of ileum&#xD;
Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).&#xD;
Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.&#xD;
We add the mesh between the edges of the defect during fascia closure.&#xD;
The skin is sutured &quot;purse string&quot; style.&#xD;
Post-Op&#xD;
Hospital discharge after verification of normal digestive transit.</description>
    <arm_group_label>MESH</arm_group_label>
    <other_name>Mesh : GORE® BIO-A®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>NO MESH</intervention_name>
    <description>Pre-operative :&#xD;
It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .&#xD;
Surgical technique:&#xD;
Peristomal incision with electrocautery&#xD;
Release the handle of ileum&#xD;
Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).&#xD;
Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.&#xD;
The skin is sutured &quot;purse string&quot; style.&#xD;
Post-Op&#xD;
- Hospital discharge after verification of normal digestive transit</description>
    <arm_group_label>NO MESH</arm_group_label>
    <other_name>Protocol Ileostomy closure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Post-operative Imaging</intervention_name>
    <description>Abdominal Tomography 1 year after ileostomy closure</description>
    <arm_group_label>MESH</arm_group_label>
    <arm_group_label>NO MESH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Pre-operative Imaging</intervention_name>
    <description>Contrast study is used to ensure the integrity of the distal anastomosis</description>
    <arm_group_label>MESH</arm_group_label>
    <arm_group_label>NO MESH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Test and C-reactive protein at 4th day</intervention_name>
    <description>All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.</description>
    <arm_group_label>MESH</arm_group_label>
    <arm_group_label>NO MESH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing a loop ileostomy closure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18&#xD;
&#xD;
          -  Pregnancy and Lactation&#xD;
&#xD;
          -  Patients allergic to polyglycolic / trimethylene carbonate&#xD;
&#xD;
          -  Carrier of prosthetic mesh in the ostomy&#xD;
&#xD;
          -  Patients presenting midline hernia.&#xD;
&#xD;
          -  Patients affected by inflammatory bowel disease&#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>Borja Villanueva Figueredo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitari Vall d'Hebron Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francesc Vallribera Valls, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitari Vall d'Hebron Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manuel Lopez-Cano, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitari Vall d'Hebron Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General Universitario Vall d´Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Borja Villanueva, MD</last_name>
      <phone>+34 629801238</phone>
      <email>b.villanueva@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Borja Villanueva Figueredo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>March 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>April 11, 2017</last_update_submitted>
  <last_update_submitted_qc>April 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Loop ileostomy</keyword>
  <keyword>Eventration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02226887
org study id: PR(AG)288/2013
nct id: NCT02226887
lead sponsor: 
has dmc: No
Design Prospective , randomized, parallel phase IV.

      Objectives Main objective

        -  Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of
           incisional hernia of the abdominal wall at the site of a loop ileostomy when it is
           "closed " to rebuild the intestinal transit. The effectiveness evaluation is done by
           tracking with scheduled patient visits for 12 months, assessing the physical examination
           the presence or absence of an incisional hernia and an abdominal tomography at the end
           of the 12 months .

      Secondary objectives Comparison of complications(morbidity and mortality) to assess safety
      and tolerability of the placement of the mesh described .
Experimental: Reinforcement with Absorbable Mesh Closure of the ileostomy closure incision is
      reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to
      the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement
      prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is
      inserted using a "sandwich" method between the edges of the incision and maintained in situ
      with a continuous polydioxanone (PDS) suture following a suture length to wound length
      (SL:WL) ratio of 4:1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Eventration
time frame: 1 year
description: Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery.
measure: Occlusive problems
time frame: 30 days after surgery
description: Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(>5days),....
This is a Clinical measure supported by image if necessary
All the morbidity problems are reported independently.
1 patient can suffer a prolonged ileus and Anastomotic stenosis and both will be reported.
measure: Iatrogenic problems
time frame: 30 days after surgery
description: Damage to structures such as ureters, bowel loops artery / iliac vein ....
This is a Surgical and Clinical measure supported by image if necessary.
All the morbidity problems are reported independently.
measure: Impaired healing
time frame: 30 days after surgery
description: Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...
This is a Clinical measure always supported by image tests.
All the morbidity problems are reported independently.
measure: Bleeding problems
time frame: 30 days after surgery
description: Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....
This is a Clinical measure supported by image if necessary.
All the morbidity problems are reported independently.
The amount of blood loss won't be specified
measure: Cardiac complications
time frame: 30 days after surgery
description: acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema
This is a Clinical measure supported by more specific tests if necessary.
All the morbidity problems are reported independently.
Cardiologist report will be required for including this items
measure: Nephro-urinary complications
time frame: 30 days after surgery
description: Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...
This is a Clinical measure supported by more specific tests if necessary.
All the morbidity problems are reported independently.
measure: Respiratory complications
time frame: 30 days after surgery
description: Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ...
This is a Clinical measure always supported by image .
All the morbidity problems are reported independently.
measure: Vascular Complications
time frame: 30 days after surgery
description: Deep venous thrombosis, phlebitis, thrombophlebitis, ...
This is a Clinical measure supported by more specific test if necessary .
All the morbidity problems are reported independently
measure: Gastrointestinal complications
time frame: 30 days after surgery
description: Liver failure, gastrointestinal bleeding, severe malnutrition, ...
This is a Clinical measure supported by blood test and further test if necessary
All the morbidity problems are reported independently.
measure: Neurological complications
time frame: 30 days after surgery
description: Disorientation, cerebral vascular accident, ...
This is a Clinical measure.
All the morbidity problems are reported independently.
Neurologist report will be required beyond disorientation.
measure: Local infection
time frame: 30 days after surgery
description: Superficial, deep, body-cavity
This is a Clinical measure supported by image if necessary
All the morbidity problems are reported independently
measure: Local complications
time frame: 30 days after surgery
description: Hematoma, seroma, evisceration
This is a Clinical measure
All the morbidity problems are reported independently
measure: Hospital stay
time frame: Days
description: Hospital stay since surgery is done
arm group label: MESH
arm group type: Experimental
arm group label: NO MESH
arm group type: Active Comparator
intervention type: Procedure
intervention name: MESH
description: Pre-operative :
It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .
Surgical technique:
Peristomal incision with electrocautery
Release the handle of ileum
Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
We add the mesh between the edges of the defect during fascia closure.
The skin is sutured "purse string" style.
Post-Op
Hospital discharge after verification of normal digestive transit.
arm group label: MESH
other name: Mesh : GORE® BIO-A®
intervention type: Procedure
intervention name: NO MESH
description: Pre-operative :
It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .
Surgical technique:
Peristomal incision with electrocautery
Release the handle of ileum
Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
The skin is sutured "purse string" style.
Post-Op
- Hospital discharge after verification of normal digestive transit
arm group label: NO MESH
other name: Protocol Ileostomy closure
intervention type: Radiation
intervention name: Post-operative Imaging
description: Abdominal Tomography 1 year after ileostomy closure
arm group label: MESH
arm group label: NO MESH
intervention type: Radiation
intervention name: Pre-operative Imaging
description: Contrast study is used to ensure the integrity of the distal anastomosis
arm group label: MESH
arm group label: NO MESH
intervention type: Other
intervention name: Blood Test and C-reactive protein at 4th day
description: All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.
arm group label: MESH
arm group label: NO MESH
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Borja Villanueva Figueredo, MD
role: Principal Investigator
affiliation: Hospital Universitari Vall d'Hebron Research Institute
last name: Francesc Vallribera Valls, MD,PhD
role: Study Director
affiliation: Hospital Universitari Vall d'Hebron Research Institute
last name: Manuel Lopez-Cano, MD, PhD
role: Study Director
affiliation: Hospital Universitari Vall d'Hebron Research Institute
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Hernia
sharing ipd: No