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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02526836 |
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Date of registration:
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11/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer
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Scientific title:
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Complete Mesocolic Excision (CME) With Central Supplying Vessel Ligation (CVL) Compared With Conventional Surgery for Colon Cancer: a Double-blinded Randomized Study |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02526836 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Egypt
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Italy
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Contacts
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Name:
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Tamer F Youssef, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oncology Center Mansoura University (OCMU), Egypt |
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Name:
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Giovanni Romano, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Cancer Institute "Fond. G. Pascale", Italy |
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Name:
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Mohamed Abdelkhalek, M.Sc |
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Address:
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Telephone:
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+201001850214 |
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Email:
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mabdelkhalek@mans.edu.eg |
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Affiliation:
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Name:
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Mohamed Abdelkhalek, M.Sc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oncology Center Mansoura University (OCMU), Egypt |
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Name:
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Adel Denewer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oncology Center Mansoura University (OCMU), Egypt |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colon Cancer
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Intervention(s)
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Procedure: Complete mesocolic excision with central vascular ligation
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Procedure: Conventional Surgery
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Primary Outcome(s)
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Lymph nodes harvest
[Time Frame: Day of surgery]
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Secondary Outcome(s)
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Postoperative outcome
[Time Frame: 1 month]
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Oncologic outcome
[Time Frame: 2 years]
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Operative outcome
[Time Frame: Day of suregry]
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Survival outcome
[Time Frame: 3 Years]
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Secondary ID(s)
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Complete Mesocolic Excision
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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