<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/NCT03001375</url>
  </required_header>
  <id_info>
    <org_study_id>6379</org_study_id>
    <nct_id>NCT03001375</nct_id>
  </id_info>
  <brief_title>Laparoscopic Splenic Flexure Mobilization</brief_title>
  <official_title>Is it Necessary to do Splenic Flexure Mobilization in Laparoscopic Resection of Upper Rectal Tumors?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This retrospective cohort study conducted on 140 patients who underwent laparoscopic anterior&#xD;
      resection for upper rectal cancer in the period from May 2011 to November 2015, comparison&#xD;
      will be done on splenic flexure mobilization excluding .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Presently, it is acknowledged that laparoscopic colectomy for left sided colorectal cancer is&#xD;
      the most common surgery operated in laparoscopic colorectal surgeries, However the most&#xD;
      debatable question in such type of operations that is it mandatory to do splenic flexure&#xD;
      mobilization or not? In the literatures colorectal surgeons divided into 2 teams, those with&#xD;
      splenic flexure mobilization in laparoscopic left colorectal resection to have tension free,&#xD;
      well vascularized anastomosis On the other hand those against splenic flexure mobilization&#xD;
      reported that omitting this step does not significantly affect the leakage rate, morbidity or&#xD;
      the oncological outcomes In this study, we evaluate the necessity of splenic flexure&#xD;
      mobilization in laparoscopic anterior resection for upper rectal tumors and its impact on the&#xD;
      operative time, total morbidity, leakage rate, oncological safety and continence level&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the incidence of leakage rate in laparoscopic anterior resection with splenic flexure mobilization versus non mobilization of splenic flexure</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Splenic Flexure Mobilization</condition>
  <arm_group>
    <arm_group_label>Mobilization group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic splenic flexure mobilization will be done.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non mobilization group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No mobilization of splenic flexure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic high anterior resection splenic flexure mobilization</intervention_name>
    <arm_group_label>Mobilization group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic high anterior resection without splenic flexure mobilization</intervention_name>
    <arm_group_label>Non mobilization group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with upper rectal tumors.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Low and mid rectal cancer&#xD;
&#xD;
          -  Splenic flexure tumors, descending colon cancer,&#xD;
&#xD;
          -  patients with associated lesions in the right or transverse colon&#xD;
&#xD;
          -  Emergency cases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Yasser Mohamed Abdel-samii</investigator_full_name>
    <investigator_title>Lecturer of general surgery</investigator_title>
  </responsible_party>
  <keyword>Laparoscopic colectomy.</keyword>
  <keyword>Splenic flexure mobilization.</keyword>
  <keyword>Anastomotic leakage.</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03001375
org study id: 6379
nct id: NCT03001375
lead sponsor: 
has dmc: No
This retrospective cohort study conducted on 140 patients who underwent laparoscopic anterior
      resection for upper rectal cancer in the period from May 2011 to November 2015, comparison
      will be done on splenic flexure mobilization excluding .
Presently, it is acknowledged that laparoscopic colectomy for left sided colorectal cancer is
      the most common surgery operated in laparoscopic colorectal surgeries, However the most
      debatable question in such type of operations that is it mandatory to do splenic flexure
      mobilization or not? In the literatures colorectal surgeons divided into 2 teams, those with
      splenic flexure mobilization in laparoscopic left colorectal resection to have tension free,
      well vascularized anastomosis On the other hand those against splenic flexure mobilization
      reported that omitting this step does not significantly affect the leakage rate, morbidity or
      the oncological outcomes In this study, we evaluate the necessity of splenic flexure
      mobilization in laparoscopic anterior resection for upper rectal tumors and its impact on the
      operative time, total morbidity, leakage rate, oncological safety and continence level
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the incidence of leakage rate in laparoscopic anterior resection with splenic flexure mobilization versus non mobilization of splenic flexure
time frame: One year
arm group label: Mobilization group
arm group type: Active Comparator
description: Laparoscopic splenic flexure mobilization will be done.
arm group label: Non mobilization group
arm group type: Active Comparator
description: No mobilization of splenic flexure.
intervention type: Procedure
intervention name: Laparoscopic high anterior resection splenic flexure mobilization
arm group label: Mobilization group
intervention type: Procedure
intervention name: Laparoscopic high anterior resection without splenic flexure mobilization
arm group label: Non mobilization group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Yasser Mohamed Abdel-samii
investigator title: Lecturer of general surgery
sharing ipd: Undecided