<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/NCT03826446</url>
  </required_header>
  <id_info>
    <org_study_id>Faculty of medicine-MenoufiaU</org_study_id>
    <nct_id>NCT03826446</nct_id>
  </id_info>
  <brief_title>Laparoscopic Versus Open Complete Mesocolic Excision With Central Vascular Ligation in Right Colon Cancer</brief_title>
  <official_title>Laparoscopic Versus Open Complete Mesocolic Excision With Central Vascular Ligation in Right Colon Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menoufia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Menoufia University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the&#xD;
      ascending colon.The aim of this study was to compare between laparoscopic and open complete&#xD;
      mesocolic excision with central vascular ligation in right colon cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer incidence and mortality rates vary markedly around the world. Globally,&#xD;
      colorectal cancer is the third most commonly diagnosed cancer in males and the second in&#xD;
      females, with 1.65 million new cases and almost 835,000 deaths in 2015. Rates are&#xD;
      substantially higher in males than in females.&#xD;
&#xD;
      The right colon has a large caliber, a thin wall, and its contents are liquid; thus,&#xD;
      obstruction is a late event. Bleeding is usually occult. Fatigue and weakness caused by&#xD;
      severe anemia may be the only complaints. Tumors sometimes grow large enough to be palpable&#xD;
      through the abdominal wall before other symptoms appear.&#xD;
&#xD;
      Curative treatment for right colon cancer includes resection of the tumor-bearing bowel&#xD;
      segment. There are standard types of operations, depending on the location of the tumor. The&#xD;
      types of standard resections are based on the knowledge of lymphatic drainage and lymph node&#xD;
      anatomy.&#xD;
&#xD;
      Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the&#xD;
      ascending colon. In 2009, Hohenberger, a German scholar, proposed the term of complete&#xD;
      mesocolic excision (CME), whose basic theory is mainly composed of two concepts in fetal&#xD;
      anatomy and surgical oncology: sharp dissection of the mesocolic plane and the parietal&#xD;
      plane. CME helps to keep the colonic mesentery intact, clarify the dissected area from&#xD;
      central lymph nodes, emphasize the importance of transecting colon-feeding blood at the root,&#xD;
      and increase the range of longitudinal enterotomy. Thus, CME provides a standardization of&#xD;
      surgeries for colon cancer.&#xD;
&#xD;
      Traditionally, approach to right colon cancer is through open exploration but this approach&#xD;
      has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and&#xD;
      delayed recovery..&#xD;
&#xD;
      Laparoscopic right colectomy (LRC) for colon cancer became a well-established technique in&#xD;
      the surgical armamentarium of colorectal operations. It has well proved advantages: reduction&#xD;
      in postoperative pain, time to return of bowel function, and length of hospital stay.&#xD;
&#xD;
      The purpose of the present study was to compare between laparoscopic and open complete&#xD;
      mesocolic excision with central vascular ligation in right colon cancer as regards technical&#xD;
      feasibility, advantages and disadvantages of both procedures.&#xD;
&#xD;
      This was prospective randomized study and was carried out on 60 patients diagnosed as&#xD;
      operable right sided colon cancer and the patients will be divided into two groups:&#xD;
&#xD;
      Group I: Open right hemicolectomy with complete mesocolic excision with central vascular&#xD;
      ligation.&#xD;
&#xD;
      Group II: Laparoscopic right hemicolectomy with complete mesocolic excision with central&#xD;
      vascular ligation.&#xD;
&#xD;
      All patients were subjected to preoperative assessment in the form of:&#xD;
&#xD;
        -  Full history.&#xD;
&#xD;
        -  Clinical evaluation and body weight.&#xD;
&#xD;
        -  Laboratory investigation (Complete blood picture, liver function tests, blood sugar,&#xD;
           blood urea, serum creatinine, prothrombin time, serum albumin and tumour markers(.&#xD;
&#xD;
        -  Imaging (chest X-ray, US abdomen, CT abdomen and pelvis).&#xD;
&#xD;
        -  Histopathology diagnosis (endoscopic biopsy, tissue diagnosis).&#xD;
&#xD;
      Operative technique&#xD;
&#xD;
      In patients of group I:&#xD;
&#xD;
        -  A standard mechanical bowel preparation will be performed 24 hours before operation.&#xD;
&#xD;
        -  The patient will be placed in the supine position and the operation will be carried out&#xD;
           in a standard manner.&#xD;
&#xD;
        -  A midline incision of about 15 to 20 cm will be made.&#xD;
&#xD;
        -  The right-sided colon will be mobilized before mesenteric division and the same vessels&#xD;
           will be dissected frequently.&#xD;
&#xD;
        -  Ileotransverse end-to-end hand anastomosis is operated and the mesenteric defect will be&#xD;
           closed.&#xD;
&#xD;
      In patients of group II:&#xD;
&#xD;
        -  A standard mechanical bowel preparation will be performed 24 hours before the operation.&#xD;
&#xD;
        -  A high-definition laparoscope will be used.&#xD;
&#xD;
        -  Under general anaesthesia the operation is carried out in standard manner, with the&#xD;
           patient in a modified lithotomy position.&#xD;
&#xD;
        -  After achieving pneumoperitoneum (12 mm Hg), a 12-mm trocar will be placed through an&#xD;
           incision just above the umbilicus, and a 30-degree laparoscope will be inserted through&#xD;
           the 12-mm trocar. The second 10-mm trocar will be inserted at the upper left quadrant of&#xD;
           the abdomen for the major acting port. The third 5-mm trocar will be inserted at the&#xD;
           lower left quadrant for the second major active port. The fourth and fifth 5-mm trocars&#xD;
           will be inserted at the upper right and lower right quadrants.&#xD;
&#xD;
        -  According to laparoscopic procedure, the position, composition, and spatial&#xD;
           relationships of the surgery planes needed for laparoscopic complete mesocolic excision&#xD;
           for right sided colic cancer cases are identified.&#xD;
&#xD;
      Intraoperatively, all patients will be assessed for:&#xD;
&#xD;
        -  Time of the procedure.&#xD;
&#xD;
        -  Amount of blood loss.&#xD;
&#xD;
      Postoperative follow up:&#xD;
&#xD;
      Patients will be followed up by the standardized follow up protocol. They will be examined by&#xD;
      the outpatient setting after:&#xD;
&#xD;
        -  2 weeks (post-operative) for: wound infection, leakage, pathological outcome (The tumor&#xD;
           node metastasis (TNM) stage, histologic grade of differentiation, number of harvested&#xD;
           lymph nodes, lymphovascular invasion, estimation of resection margins).&#xD;
&#xD;
        -  Every 3 months for 1-2 years by: history taking, physical examination, carcinoembryonic&#xD;
           antigen measurement,&#xD;
&#xD;
        -  Every 6 months for 1-2 years by: chest, abdomen-pelvic computed tomography for detection&#xD;
           of local or systemic recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 17, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative time in open and laparoscopic complete mesocolic excision groups in right cancer colon</measure>
    <time_frame>1-3 years</time_frame>
    <description>Comparing the operative time between laparoscopic and open complete mesocolic excision with central artery ligation groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incision length in open and laparoscopic complete mesocolic excision groups in right cancer colon</measure>
    <time_frame>1-3 years</time_frame>
    <description>Comparing the incision length between laparoscopic and open complete mesocolic excision with central artery ligation groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital stay duration in open and laparoscopic complete mesocolic excision groups in right cancer colon</measure>
    <time_frame>1-3</time_frame>
    <description>Comparing the hospital stay duration between laparoscopic and open complete mesocolic excision with central artery ligation groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Histopathological findings in open and laparoscopic complete mesocolic excision groups in right cancer colon</measure>
    <time_frame>1-3 years</time_frame>
    <description>Comparing the histopathological findings between laparoscopic and open complete mesocolic excision with central artery ligation groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative complications in open and laparoscopic complete mesocolic excision groups in right cancer colon</measure>
    <time_frame>1-3 years</time_frame>
    <description>Comparing the post-operative complications between laparoscopic and open complete mesocolic excision with central artery ligation groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrence rate in open and laparoscopic complete mesocolic excision groups in right cancer colon</measure>
    <time_frame>1-3 years</time_frame>
    <description>Comparing the recurrence rate between laparoscopic and open complete mesocolic excision with central artery ligation groups</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>Open Surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients diagnosed as operable right sided colon cancer were enrolled in this study and did open complete mesocolic excision procedures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic Surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic complete mesocolic excision procedures</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer.</description>
    <arm_group_label>Laparoscopic Surgery</arm_group_label>
    <arm_group_label>Open Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Only operable cases of right colon cancer by (CT scan criteria) which include:&#xD;
&#xD;
               1. No permeation of surrounding fat planes.&#xD;
&#xD;
               2. No encasement of major vascular structures.&#xD;
&#xD;
               3. No extensive local spread.&#xD;
&#xD;
               4. No distant metastases or peritoneal infiltration were included in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1- All cases with perforation or obstruction. 2- Metastatic colon cancer. 3- Patients&#xD;
             undergoing colectomy including another part of the colon than right colon.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of medicine</name>
      <address>
        <city>ShebinElkom</city>
        <state>Menoufia</state>
        <zip>32511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Menoufia University</investigator_affiliation>
    <investigator_full_name>Karim Mohamed Shady</investigator_full_name>
    <investigator_title>kshady- Principal investigstor</investigator_title>
  </responsible_party>
  <keyword>Right colon cancer</keyword>
  <keyword>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>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/NCT03826446
org study id: Faculty of medicine-MenoufiaU
nct id: NCT03826446
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the
      ascending colon.The aim of this study was to compare between laparoscopic and open complete
      mesocolic excision with central vascular ligation in right colon cancer.
Colorectal cancer incidence and mortality rates vary markedly around the world. Globally,
      colorectal cancer is the third most commonly diagnosed cancer in males and the second in
      females, with 1.65 million new cases and almost 835,000 deaths in 2015. Rates are
      substantially higher in males than in females.

      The right colon has a large caliber, a thin wall, and its contents are liquid; thus,
      obstruction is a late event. Bleeding is usually occult. Fatigue and weakness caused by
      severe anemia may be the only complaints. Tumors sometimes grow large enough to be palpable
      through the abdominal wall before other symptoms appear.

      Curative treatment for right colon cancer includes resection of the tumor-bearing bowel
      segment. There are standard types of operations, depending on the location of the tumor. The
      types of standard resections are based on the knowledge of lymphatic drainage and lymph node
      anatomy.

      Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the
      ascending colon. In 2009, Hohenberger, a German scholar, proposed the term of complete
      mesocolic excision (CME), whose basic theory is mainly composed of two concepts in fetal
      anatomy and surgical oncology: sharp dissection of the mesocolic plane and the parietal
      plane. CME helps to keep the colonic mesentery intact, clarify the dissected area from
      central lymph nodes, emphasize the importance of transecting colon-feeding blood at the root,
      and increase the range of longitudinal enterotomy. Thus, CME provides a standardization of
      surgeries for colon cancer.

      Traditionally, approach to right colon cancer is through open exploration but this approach
      has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and
      delayed recovery..

      Laparoscopic right colectomy (LRC) for colon cancer became a well-established technique in
      the surgical armamentarium of colorectal operations. It has well proved advantages: reduction
      in postoperative pain, time to return of bowel function, and length of hospital stay.

      The purpose of the present study was to compare between laparoscopic and open complete
      mesocolic excision with central vascular ligation in right colon cancer as regards technical
      feasibility, advantages and disadvantages of both procedures.

      This was prospective randomized study and was carried out on 60 patients diagnosed as
      operable right sided colon cancer and the patients will be divided into two groups:

      Group I: Open right hemicolectomy with complete mesocolic excision with central vascular
      ligation.

      Group II: Laparoscopic right hemicolectomy with complete mesocolic excision with central
      vascular ligation.

      All patients were subjected to preoperative assessment in the form of:

        -  Full history.

        -  Clinical evaluation and body weight.

        -  Laboratory investigation (Complete blood picture, liver function tests, blood sugar,
           blood urea, serum creatinine, prothrombin time, serum albumin and tumour markers(.

        -  Imaging (chest X-ray, US abdomen, CT abdomen and pelvis).

        -  Histopathology diagnosis (endoscopic biopsy, tissue diagnosis).

      Operative technique

      In patients of group I:

        -  A standard mechanical bowel preparation will be performed 24 hours before operation.

        -  The patient will be placed in the supine position and the operation will be carried out
           in a standard manner.

        -  A midline incision of about 15 to 20 cm will be made.

        -  The right-sided colon will be mobilized before mesenteric division and the same vessels
           will be dissected frequently.

        -  Ileotransverse end-to-end hand anastomosis is operated and the mesenteric defect will be
           closed.

      In patients of group II:

        -  A standard mechanical bowel preparation will be performed 24 hours before the operation.

        -  A high-definition laparoscope will be used.

        -  Under general anaesthesia the operation is carried out in standard manner, with the
           patient in a modified lithotomy position.

        -  After achieving pneumoperitoneum (12 mm Hg), a 12-mm trocar will be placed through an
           incision just above the umbilicus, and a 30-degree laparoscope will be inserted through
           the 12-mm trocar. The second 10-mm trocar will be inserted at the upper left quadrant of
           the abdomen for the major acting port. The third 5-mm trocar will be inserted at the
           lower left quadrant for the second major active port. The fourth and fifth 5-mm trocars
           will be inserted at the upper right and lower right quadrants.

        -  According to laparoscopic procedure, the position, composition, and spatial
           relationships of the surgery planes needed for laparoscopic complete mesocolic excision
           for right sided colic cancer cases are identified.

      Intraoperatively, all patients will be assessed for:

        -  Time of the procedure.

        -  Amount of blood loss.

      Postoperative follow up:

      Patients will be followed up by the standardized follow up protocol. They will be examined by
      the outpatient setting after:

        -  2 weeks (post-operative) for: wound infection, leakage, pathological outcome (The tumor
           node metastasis (TNM) stage, histologic grade of differentiation, number of harvested
           lymph nodes, lymphovascular invasion, estimation of resection margins).

        -  Every 3 months for 1-2 years by: history taking, physical examination, carcinoembryonic
           antigen measurement,

        -  Every 6 months for 1-2 years by: chest, abdomen-pelvic computed tomography for detection
           of local or systemic recurrence.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Operative time in open and laparoscopic complete mesocolic excision groups in right cancer colon
time frame: 1-3 years
description: Comparing the operative time between laparoscopic and open complete mesocolic excision with central artery ligation groups
measure: Incision length in open and laparoscopic complete mesocolic excision groups in right cancer colon
time frame: 1-3 years
description: Comparing the incision length between laparoscopic and open complete mesocolic excision with central artery ligation groups
measure: Hospital stay duration in open and laparoscopic complete mesocolic excision groups in right cancer colon
time frame: 1-3
description: Comparing the hospital stay duration between laparoscopic and open complete mesocolic excision with central artery ligation groups
measure: Histopathological findings in open and laparoscopic complete mesocolic excision groups in right cancer colon
time frame: 1-3 years
description: Comparing the histopathological findings between laparoscopic and open complete mesocolic excision with central artery ligation groups
measure: Post-operative complications in open and laparoscopic complete mesocolic excision groups in right cancer colon
time frame: 1-3 years
description: Comparing the post-operative complications between laparoscopic and open complete mesocolic excision with central artery ligation groups
measure: Recurrence rate in open and laparoscopic complete mesocolic excision groups in right cancer colon
time frame: 1-3 years
description: Comparing the recurrence rate between laparoscopic and open complete mesocolic excision with central artery ligation groups
arm group label: Open Surgery
arm group type: Other
description: Patients diagnosed as operable right sided colon cancer were enrolled in this study and did open complete mesocolic excision procedures
arm group label: Laparoscopic Surgery
arm group type: Other
description: Patients diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic complete mesocolic excision procedures
intervention type: Procedure
intervention name: Surgery
description: laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer.
arm group label: Laparoscopic Surgery
arm group label: Open Surgery
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Menoufia University
investigator full name: Karim Mohamed Shady
investigator title: kshady- Principal investigstor
mesh term: Colonic Neoplasms
sharing ipd: Undecided