<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/NCT03769922</url>
  </required_header>
  <id_info>
    <org_study_id>2018NZKY-025-02</org_study_id>
    <nct_id>NCT03769922</nct_id>
  </id_info>
  <brief_title>Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease</brief_title>
  <official_title>The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinling Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital of Limerick</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sir Run Run Shaw Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jinling Hospital, China</source>
  <oversight_info>
    <has_dmc>No</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>
      The study evaluates whether there is a reduction in the rate of postoperative progression of&#xD;
      the disease following extensive mesenteric excision (EME), when compared to that of limited&#xD;
      mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease.&#xD;
      Half of participants will receive EME, while the other half will receive LME.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EME and LME are the two surgical procedures which are commonly used in the treatment of&#xD;
      Crohn's disease. However, the areas of the mesenteric tissue resected are different.&#xD;
&#xD;
      EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of&#xD;
      ileocolic artery and vein.&#xD;
&#xD;
      LME represents that the mesentery is retained, i.e. &quot;Close shave&quot; or 3 cm from the border of&#xD;
      bowel (using whatever approach - clips, or haemostatic vessel sealing device).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accumulated 5-year postoperative surgical recurrence</measure>
    <time_frame>5 years after the first surgery</time_frame>
    <description>The requirement for repeat surgery for a Crohn's disease related indication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accumulated 5-year endoscopic recurrence</measure>
    <time_frame>5 years after the first surgery</time_frame>
    <description>Disease proximal to the anastomosis or in the perianastomotic are considered to be a endoscopic recurrence (Rutgeert's score i2, or higher, disease in other sites is not considered recurrence)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulated 5-year clinical recurrence</measure>
    <time_frame>5 years after the first surgery</time_frame>
    <description>The presence of endoscopic disease (i2, or higher) or radiological evidence plus the presence of symptoms attributable to Crohn's disease that are severe enough to require medical or surgical treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>postoperative operation-related complications</measure>
    <time_frame>30 day</time_frame>
    <description>30-day postoperative morbidity</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Postoperative Surgical Recurrence</condition>
  <arm_group>
    <arm_group_label>Extensive mesenteric resection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Limited mesenteric excision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mesentery is retained, i.e. &quot;Close shave&quot; or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Extensive mesenteric resection</intervention_name>
    <description>The mesentery is resected avoiding the root region.</description>
    <arm_group_label>Extensive mesenteric resection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Limited mesenteric excision</intervention_name>
    <description>The mesentery is retained.</description>
    <arm_group_label>Limited mesenteric excision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Crohn's disease limited to the distal ileum and/or right colon receiving&#xD;
             their index ileocolonic resection&#xD;
&#xD;
          -  Patients with a documented history of Crohn's disease based on endoscopic,&#xD;
             radiological, or histological criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or willingness to become pregnant in the following year&#xD;
&#xD;
          -  Previous ileocolic resection history&#xD;
&#xD;
          -  Patients having Crohn's disease lesion at a gastrointestinal site other than the&#xD;
             terminal ileum cecum, or right colon&#xD;
&#xD;
          -  Patients having an internal fistula which required resection of another segment of&#xD;
             bowel&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhu Weiming</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jinling Hospital, Nanjing, China.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Calvin Coffey</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Limerick, Limerick, Ireland.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luca Stocchi</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Yi, PhD</last_name>
    <phone>+86 13851843735</phone>
    <email>liyi.jlh@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>General Hospital of Eastern Theater Command</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Li</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://academic.oup.com/ibdjournal/article-abstract/21/11/2613/4579250?redirectedFrom=fulltext</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Coffey CJ, Kiernan MG, Sahebally SM, Jarrar A, Burke JP, Kiely PA, Shen B, Waldron D, Peirce C, Moloney M, Skelly M, Tibbitts P, Hidayat H, Faul PN, Healy V, O'Leary PD, Walsh LG, Dockery P, O'Connell RP, Martin ST, Shanahan F, Fiocchi C, Dunne CP. Inclusion of the Mesentery in Ileocolic Resection for Crohn's Disease is Associated With Reduced Surgical Recurrence. J Crohns Colitis. 2018 Nov 9;12(10):1139-1150. doi: 10.1093/ecco-jcc/jjx187.</citation>
    <PMID>29309546</PMID>
  </reference>
  <reference>
    <citation>Li Y, Zhu W, Gong J, Zhang W, Gu L, Guo Z, Cao L, Shen B, Li N, Li J. Visceral fat area is associated with a high risk for early postoperative recurrence in Crohn's disease. Colorectal Dis. 2015 Mar;17(3):225-34. doi: 10.1111/codi.12798.</citation>
    <PMID>25307174</PMID>
  </reference>
  <reference>
    <citation>Li Y, Ge Y, Gong J, Zhu W, Cao L, Guo Z, Gu L, Li J. Mesenteric Lymphatic Vessel Density Is Associated with Disease Behavior and Postoperative Recurrence in Crohn's Disease. J Gastrointest Surg. 2018 Dec;22(12):2125-2132. doi: 10.1007/s11605-018-3884-9. Epub 2018 Jul 24.</citation>
    <PMID>30043133</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>Weiming Zhu</investigator_full_name>
    <investigator_title>Chief of general surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Recurrence</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/NCT03769922
org study id: 2018NZKY-025-02
nct id: NCT03769922
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluates whether there is a reduction in the rate of postoperative progression of
      the disease following extensive mesenteric excision (EME), when compared to that of limited
      mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease.
      Half of participants will receive EME, while the other half will receive LME.
EME and LME are the two surgical procedures which are commonly used in the treatment of
      Crohn's disease. However, the areas of the mesenteric tissue resected are different.

      EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of
      ileocolic artery and vein.

      LME represents that the mesentery is retained, i.e. "Close shave" or 3 cm from the border of
      bowel (using whatever approach - clips, or haemostatic vessel sealing device).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Accumulated 5-year postoperative surgical recurrence
time frame: 5 years after the first surgery
description: The requirement for repeat surgery for a Crohn's disease related indication.
measure: Accumulated 5-year endoscopic recurrence
time frame: 5 years after the first surgery
description: Disease proximal to the anastomosis or in the perianastomotic are considered to be a endoscopic recurrence (Rutgeert's score i2, or higher, disease in other sites is not considered recurrence)
measure: Accumulated 5-year clinical recurrence
time frame: 5 years after the first surgery
description: The presence of endoscopic disease (i2, or higher) or radiological evidence plus the presence of symptoms attributable to Crohn's disease that are severe enough to require medical or surgical treatment.
measure: postoperative operation-related complications
time frame: 30 day
description: 30-day postoperative morbidity
arm group label: Extensive mesenteric resection
arm group type: Experimental
description: Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
arm group label: Limited mesenteric excision
arm group type: Active Comparator
description: Mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
intervention type: Procedure
intervention name: Extensive mesenteric resection
description: The mesentery is resected avoiding the root region.
arm group label: Extensive mesenteric resection
intervention type: Procedure
intervention name: Limited mesenteric excision
description: The mesentery is retained.
arm group label: Limited mesenteric excision
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Zhu Weiming
role: Principal Investigator
affiliation: Jinling Hospital, Nanjing, China.
last name: John Calvin Coffey
role: Principal Investigator
affiliation: University Hospital Limerick, Limerick, Ireland.
last name: Luca Stocchi
role: Principal Investigator
affiliation: The Cleveland Clinic
last name: Li Yi, PhD
phone: +86 13851843735
email: liyi.jlh@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
url: https://academic.oup.com/ibdjournal/article-abstract/21/11/2613/4579250?redirectedFrom=fulltext
description: Related Info
citation: Coffey CJ, Kiernan MG, Sahebally SM, Jarrar A, Burke JP, Kiely PA, Shen B, Waldron D, Peirce C, Moloney M, Skelly M, Tibbitts P, Hidayat H, Faul PN, Healy V, O'Leary PD, Walsh LG, Dockery P, O'Connell RP, Martin ST, Shanahan F, Fiocchi C, Dunne CP. Inclusion of the Mesentery in Ileocolic Resection for Crohn's Disease is Associated With Reduced Surgical Recurrence. J Crohns Colitis. 2018 Nov 9;12(10):1139-1150. doi: 10.1093/ecco-jcc/jjx187.
PMID: 29309546
citation: Li Y, Zhu W, Gong J, Zhang W, Gu L, Guo Z, Cao L, Shen B, Li N, Li J. Visceral fat area is associated with a high risk for early postoperative recurrence in Crohn's disease. Colorectal Dis. 2015 Mar;17(3):225-34. doi: 10.1111/codi.12798.
PMID: 25307174
citation: Li Y, Ge Y, Gong J, Zhu W, Cao L, Guo Z, Gu L, Li J. Mesenteric Lymphatic Vessel Density Is Associated with Disease Behavior and Postoperative Recurrence in Crohn's Disease. J Gastrointest Surg. 2018 Dec;22(12):2125-2132. doi: 10.1007/s11605-018-3884-9. Epub 2018 Jul 24.
PMID: 30043133
responsible party type: Principal Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: Weiming Zhu
investigator title: Chief of general surgery
mesh term: Crohn Disease
mesh term: Recurrence
sharing ipd: No