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Trial record 33 of 5151 for:    colon cancer

The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment

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ClinicalTrials.gov Identifier: NCT04079946
Recruitment Status : Not yet recruiting
First Posted : September 5, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Amr Essam Hassan Farghly, Assiut University

Brief Summary:
Cancer Colon is one of the major public health problems worldwide. Complete eradication of the tumor with no recurrence or residual masses is a challenge which faces all the surgeons and medical staff all over the world. A lot of techniques were used to ensure 100 % eradication of the tumor and to cure the patients from cancer. Total Mesocolic Excision with Central Vessel Ligation is one of the recent techniques used for colon cancer surgeries. Here in the research the investigators answer the question of how this technique is superior and more beneficial in complete eradication of the tumor than the conventional surgery for colon cancer

Condition or disease Intervention/treatment Phase
Cancer Colon Procedure: Total Mesocolic Excision with Central Vessel Ligation Procedure: conventional surgery of cancer colon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 1, 2021

Arm Intervention/treatment
Active Comparator: patients for whom Complete mesocolic excision will be done Procedure: Total Mesocolic Excision with Central Vessel Ligation
sharp dissection of the anatomical layers and the dissection of the visceral plane from the parietal one . In addition a central division of the feeding arteries at their origins is performed at the level of superior mesenteric artery for tumors of the right colon and at the level of inferior mesenteric artery or the aorta for tumors of the left colon .this allows for removal of the maximum number of lymph nodes possible.

Active Comparator: patients had conventional surgery before Procedure: conventional surgery of cancer colon
removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon




Primary Outcome Measures :
  1. Lymph nodes harvest [ Time Frame: Two years ]
    Number of retrieved lymph nodes can be extracted by this technique



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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:

  • • Adult male and female Age of or above 18 years.

    • 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)]
    • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease
    • Written informed consent

Exclusion Criteria:

  • • Contraindications to major surgery and American Society of Anaesthesiologists (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.
    • Pregnant women
    • Use of systemic steroids.
    • 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): NCT04079946


Contacts
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Contact: Amr E. Hassan, resident Doctor 01004664295 amrelfayed@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Mostafa A. Hassanein, professor Assiut University
Study Director: Mohamed B. Kotb, profeesor Assiut University
Study Director: Mahmoud T. Ahmed, lecturer Assiut University

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Responsible Party: Amr Essam Hassan Farghly, Resident Doctor At Assuit University Hospital, Assiut University
ClinicalTrials.gov Identifier: NCT04079946     History of Changes
Other Study ID Numbers: AssiutU93
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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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 Amr Essam Hassan Farghly, Assiut University:
cancer colon
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