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Laparoscopic Versus Open Complete Mesocolic Excision With Central Vascular Ligation in Right Colon Cancer

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ClinicalTrials.gov Identifier: NCT03826446
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Karim Mohamed Shady, Menoufia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Surgery Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Versus Open Complete Mesocolic Excision With Central Vascular Ligation in Right Colon Cancer
Actual Study Start Date : January 13, 2016
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
Open Surgery
Patients diagnosed as operable right sided colon cancer were enrolled in this study and did open complete mesocolic excision procedures
Procedure: Surgery
laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer.

Laparoscopic Surgery
Patients diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic complete mesocolic excision procedures
Procedure: Surgery
laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer.




Primary Outcome Measures :
  1. Operative time in open and laparoscopic complete mesocolic excision groups in right cancer colon [ Time Frame: 1-3 years ]
    Comparing the operative time between laparoscopic and open complete mesocolic excision with central artery ligation groups

  2. Incision length in open and laparoscopic complete mesocolic excision groups in right cancer colon [ Time Frame: 1-3 years ]
    Comparing the incision length between laparoscopic and open complete mesocolic excision with central artery ligation groups

  3. Hospital stay duration in open and laparoscopic complete mesocolic excision groups in right cancer colon [ Time Frame: 1-3 ]
    Comparing the hospital stay duration between laparoscopic and open complete mesocolic excision with central artery ligation groups

  4. Histopathological findings in open and laparoscopic complete mesocolic excision groups in right cancer colon [ Time Frame: 1-3 years ]
    Comparing the histopathological findings between laparoscopic and open complete mesocolic excision with central artery ligation groups

  5. Post-operative complications in open and laparoscopic complete mesocolic excision groups in right cancer colon [ Time Frame: 1-3 years ]
    Comparing the post-operative complications between laparoscopic and open complete mesocolic excision with central artery ligation groups

  6. Recurrence rate in open and laparoscopic complete mesocolic excision groups in right cancer colon [ Time Frame: 1-3 years ]
    Comparing the recurrence rate between laparoscopic and open complete mesocolic excision with central artery ligation groups



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Only operable cases of right colon cancer by (CT scan criteria) which include:

    1. No permeation of surrounding fat planes.
    2. No encasement of major vascular structures.
    3. No extensive local spread.
    4. No distant metastases or peritoneal infiltration were included in this study.

Exclusion Criteria:

  • 1- All cases with perforation or obstruction. 2- Metastatic colon cancer. 3- Patients undergoing colectomy including another part of the colon than right colon.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826446


Locations
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Egypt
Faculty of medicine
ShebinElkom, Menoufia, Egypt, 32511
Sponsors and Collaborators
Menoufia University

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Responsible Party: Karim Mohamed Shady, kshady- Principal investigstor, Menoufia University
ClinicalTrials.gov Identifier: NCT03826446     History of Changes
Other Study ID Numbers: Faculty of medicine-MenoufiaU
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karim Mohamed Shady, Menoufia University:
Right colon cancer
Mesocolic excision

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases