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Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer

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ClinicalTrials.gov Identifier: NCT02526836
Recruitment Status : Unknown
Verified November 2017 by Mohamed Abdelkhalek, Mansoura University.
Recruitment status was:  Recruiting
First Posted : August 18, 2015
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Abdelkhalek, Mansoura University

Brief Summary:
The aim of this study is to compare between complete mesocolic excision with central vascular ligation and conventional surgery of colon cancer regarding number of harvested lymph nodes, surgical outcome and complications.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Conventional Surgery Procedure: Complete mesocolic excision with central vascular ligation Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Complete Mesocolic Excision (CME) With Central Supplying Vessel Ligation (CVL) Compared With Conventional Surgery for Colon Cancer: a Double-blinded Randomized Study
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Comparison group

including the number of cases with complete data who underwent surgery using the conventional method.

Conventional surgery

Procedure: Conventional Surgery
removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon

Active Comparator: Intervention group

including a convenient sample of about 20 patients which is expected to be recruited, for whom Complete Mesocolic Excision (CME) and Central Vascular Ligation (CVL) will be done.

Complete mesocolic excision with central vascular ligation

Procedure: Complete mesocolic excision with central vascular ligation
excision of the whole mesocolon plus ligation of the supplying blood vessel centrally




Primary Outcome Measures :
  1. Lymph nodes harvest [ Time Frame: Day of surgery ]
    Number of retrieved lymph nodes


Secondary Outcome Measures :
  1. Oncologic outcome [ Time Frame: 2 years ]
    Number of patients with local or distant recurrence after the surgery.

  2. Operative outcome [ Time Frame: Day of suregry ]
    A composite outcome of the Operative time, blood loss, blood transfusion, intraoperative morbidities and mortality

  3. Postoperative outcome [ Time Frame: 1 month ]
    A composite outcome of the number of morbidities and mortalities in the postoperative setting

  4. Survival outcome [ Time Frame: 3 Years ]
    Number of patients with 2 year free survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically proven adenocarcinoma (including mucinous and signet-ring cell) or adenosquamous carcinoma on endoscopic biopsy.
  • Tumor localization at the caecum, ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid on preoperative endoscopy and radiographic imaging [barium enema or computed tomography (CT)] without location of the lower border of the tumor at the rectum.
  • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
  • Body mass index ≤ 35.
  • Sufficient organ function including cardiovascular system and liver.
  • Written informed consent.

Exclusion Criteria:

  • Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment.
  • Infectious disease requiring treatment.
  • Body temperature ≥ 38 °C.
  • Pregnant women.
  • History of psychiatric disease.
  • Use of systemic steroids.
  • History of myocardial infarction or unstable angina pectoris within 6 months.
  • Severe pulmonary emphysema or pulmonary fibrosis

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): NCT02526836


Contacts
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Contact: Mohamed Abdelkhalek, M.Sc +201001850214 mabdelkhalek@mans.edu.eg
Contact: Ahmed Setit, MD asetit@mans.edu.eg

Locations
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Egypt
Oncology Center Mansoura University (OCMU), Egypt Recruiting
El Mansura, Dakahlia, Egypt, 35516
Contact: Mohamed Abdelkhalek, M.Sc    +201001850214    mabdelkhalek@mans.edu.eg   
Contact: Ahmed Setit, MD       asetit@mans.edu.eg   
Sub-Investigator: Osama Eldamshety         
Italy
National Cancer Institute "Fond. G. Pascale" Recruiting
Naples, Italy, 80131
Contact: Giovanni Romano, MD    +39 081 5903 311    gromano53@katamail.com   
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mohamed Abdelkhalek, M.Sc Oncology Center Mansoura University (OCMU), Egypt
Principal Investigator: Giovanni Romano, MD National Cancer Institute "Fond. G. Pascale", Italy
Study Chair: Adel Denewer, MD Oncology Center Mansoura University (OCMU), Egypt
Study Director: Tamer F Youssef, MD Oncology Center Mansoura University (OCMU), Egypt

Additional Information:
Publications:
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Responsible Party: Mohamed Abdelkhalek, Assistant Lecturer of Surgical Oncology, Mansoura University
ClinicalTrials.gov Identifier: NCT02526836     History of Changes
Other Study ID Numbers: Complete Mesocolic Excision
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes
Supporting Materials: Study Protocol
Keywords provided by Mohamed Abdelkhalek, Mansoura University:
colon cancer mesocolic excision central ligation
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