<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/NCT04434508</url>
  </required_header>
  <id_info>
    <org_study_id>laparoscopic hemicolectomy</org_study_id>
    <nct_id>NCT04434508</nct_id>
  </id_info>
  <brief_title>Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer</brief_title>
  <acronym>CME</acronym>
  <official_title>Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of&#xD;
      laparoscopic right hemicolectomy with CME and CVL compared to open surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of&#xD;
      laparoscopic right hemicolectomy with CME and CVL compared to open surgery.&#xD;
&#xD;
      Enrolled patients in the study were randomized to either laparoscopic or open right&#xD;
      hemicolectomy with CME and central vascular ligation. The randomization process was performed&#xD;
      using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.&#xD;
&#xD;
      The primary outcome was the number of lymph nodes (LNs) harvested among both groups.&#xD;
      Secondary outcomes included operative time, blood loss, postoperative complications, and&#xD;
      hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">January 25, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>
    <intervention_model_description>Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>the number of lymph nodes (LNs) harvested among both groups</measure>
    <time_frame>30 DAYS</time_frame>
    <description>the number of lymph nodes (LNs) harvested among both groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>operative time</measure>
    <time_frame>INTRAOPERATIVE</time_frame>
    <description>operative time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood loss,</measure>
    <time_frame>intraoperative</time_frame>
    <description>blood loss,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-operative complications</measure>
    <time_frame>30 days</time_frame>
    <description>post-operative complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Colonic Cancer</condition>
  <arm_group>
    <arm_group_label>laparoscopic right hemicolectomy with CME and central v</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>laparoscopic right hemicolectomy with CME and central v</description>
  </arm_group>
  <arm_group>
    <arm_group_label>open right hemicolectomy with CME and central v</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>open right hemicolectomy with CME and central v</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic right hemicolectomy with CME and central v</intervention_name>
    <description>laparoscopic right hemicolectomy with CME and central v</description>
    <arm_group_label>laparoscopic right hemicolectomy with CME and central v</arm_group_label>
    <other_name>LHC with CME</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open right hemicolectomy with CME and central v</intervention_name>
    <description>Open right hemicolectomy with CME and central v</description>
    <arm_group_label>open right hemicolectomy with CME and central v</arm_group_label>
    <other_name>ORH with CME</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with right colonic cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with distant metastasis, large tumors with extra-colonic invasion emergency&#xD;
             presentation (bowel obstruction or perforation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayman E Nakeeb</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University, Gastrointestinal Surgery Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed E el sorogy, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mansoura University, Gastrointestinal Surgery Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ayman El Nakeeb</name>
      <address>
        <city>Mansoura</city>
        <state>Outside U.S And Canada</state>
        <zip>35111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.mans.edu.eg/en/</url>
    <description>Mansoura university</description>
  </link>
  <reference>
    <citation>Cho MS, Baek SJ, Hur H, Soh Min B, Baik SH, Kyu Kim N. Modified complete mesocolic excision with central vascular ligation for the treatment of right-sided colon cancer: long-term outcomes and prognostic factors. Ann Surg. 2015 Apr;261(4):708-15. doi: 10.1097/SLA.0000000000000831.</citation>
    <PMID>25072438</PMID>
  </reference>
  <results_reference>
    <citation>Vajda K, Horti I, Cserni G, Bori R, Sikorszki L. [Laparoscopic and open complete mesocolic excision in right-sided colon cancer compared with open and laparoscopic surgery]. Magy Seb. 2020 Mar;73(1):23-28. doi: 10.1556/1046.73.2020.1.3. Hungarian.</citation>
    <PMID>32172577</PMID>
  </results_reference>
  <results_reference>
    <citation>Dewulf M, Kalmar A, Vandenberk B, Muysoms F, Defoort B, Claeys D, Pletinckx P. Complete mesocolic excision does not increase short-term complications in laparoscopic left-sided colectomies: a comparative retrospective single-center study. Langenbecks Arch Surg. 2019 Aug;404(5):557-564. doi: 10.1007/s00423-019-01797-8. Epub 2019 Jun 26.</citation>
    <PMID>31243573</PMID>
  </results_reference>
  <results_reference>
    <citation>Emmanuel A, Haji A. Complete mesocolic excision and extended (D3) lymphadenectomy for colonic cancer: is it worth that extra effort? A review of the literature. Int J Colorectal Dis. 2016 Apr;31(4):797-804. doi: 10.1007/s00384-016-2502-0. Epub 2016 Jan 30.</citation>
    <PMID>26833471</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Ayman El Nakeeb</investigator_full_name>
    <investigator_title>gastrointestinal surgical center, Mansoura University</investigator_title>
  </responsible_party>
  <keyword>Colonic Cancer</keyword>
  <keyword>laparoscopic right hemicolectomy</keyword>
  <keyword>complete mesocolic excision</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study Protocol</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>6 months</ipd_time_frame>
    <ipd_access_criteria>elnakeebayman@yahoo.com</ipd_access_criteria>
    <ipd_url>http://www.mans.edu.eg/en/</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>Ayman El Nakeeb</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://www.mans.edu.eg/en/</doc_url>
      <doc_comment>elnakeebayman@yahoo.com</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT04434508
org study id: laparoscopic hemicolectomy
nct id: NCT04434508
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of
      laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of
      laparoscopic right hemicolectomy with CME and CVL compared to open surgery.

      Enrolled patients in the study were randomized to either laparoscopic or open right
      hemicolectomy with CME and central vascular ligation. The randomization process was performed
      using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.

      The primary outcome was the number of lymph nodes (LNs) harvested among both groups.
      Secondary outcomes included operative time, blood loss, postoperative complications, and
      hospital stay.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
primary purpose: Treatment
masking: Single (Participant)
masking description: Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
measure: the number of lymph nodes (LNs) harvested among both groups
time frame: 30 DAYS
description: the number of lymph nodes (LNs) harvested among both groups
measure: operative time
time frame: INTRAOPERATIVE
description: operative time
measure: blood loss,
time frame: intraoperative
description: blood loss,
measure: post-operative complications
time frame: 30 days
description: post-operative complications
arm group label: laparoscopic right hemicolectomy with CME and central v
arm group type: Active Comparator
description: laparoscopic right hemicolectomy with CME and central v
arm group label: open right hemicolectomy with CME and central v
arm group type: Active Comparator
description: open right hemicolectomy with CME and central v
intervention type: Procedure
intervention name: laparoscopic right hemicolectomy with CME and central v
description: laparoscopic right hemicolectomy with CME and central v
arm group label: laparoscopic right hemicolectomy with CME and central v
other name: LHC with CME
intervention type: Procedure
intervention name: Open right hemicolectomy with CME and central v
description: Open right hemicolectomy with CME and central v
arm group label: open right hemicolectomy with CME and central v
other name: ORH with CME
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ayman E Nakeeb
role: Principal Investigator
affiliation: Mansoura University, Gastrointestinal Surgery Center
last name: Mohamed E el sorogy, MD
role: Study Director
affiliation: Mansoura University, Gastrointestinal Surgery Center
facility: 
country: Egypt
url: http://www.mans.edu.eg/en/
description: Mansoura university
citation: Cho MS, Baek SJ, Hur H, Soh Min B, Baik SH, Kyu Kim N. Modified complete mesocolic excision with central vascular ligation for the treatment of right-sided colon cancer: long-term outcomes and prognostic factors. Ann Surg. 2015 Apr;261(4):708-15. doi: 10.1097/SLA.0000000000000831.
PMID: 25072438
citation: Vajda K, Horti I, Cserni G, Bori R, Sikorszki L. [Laparoscopic and open complete mesocolic excision in right-sided colon cancer compared with open and laparoscopic surgery]. Magy Seb. 2020 Mar;73(1):23-28. doi: 10.1556/1046.73.2020.1.3. Hungarian.
PMID: 32172577
citation: Dewulf M, Kalmar A, Vandenberk B, Muysoms F, Defoort B, Claeys D, Pletinckx P. Complete mesocolic excision does not increase short-term complications in laparoscopic left-sided colectomies: a comparative retrospective single-center study. Langenbecks Arch Surg. 2019 Aug;404(5):557-564. doi: 10.1007/s00423-019-01797-8. Epub 2019 Jun 26.
PMID: 31243573
citation: Emmanuel A, Haji A. Complete mesocolic excision and extended (D3) lymphadenectomy for colonic cancer: is it worth that extra effort? A review of the literature. Int J Colorectal Dis. 2016 Apr;31(4):797-804. doi: 10.1007/s00384-016-2502-0. Epub 2016 Jan 30.
PMID: 26833471
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Ayman El Nakeeb
investigator title: gastrointestinal surgical center, Mansoura University
mesh term: Colonic Neoplasms
sharing ipd: Yes
ipd description: Study Protocol
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: 6 months
ipd access criteria: elnakeebayman@yahoo.com
ipd url: http://www.mans.edu.eg/en/
study doc: 