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

NCT04079946 | Unknown DMC

• 1 other identifier: AssiutU93
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cancer Colon

Keywords

cancer colon

Outcome Measures

Primary Outcomes (1)

• Lymph nodes harvest

  Number of retrieved lymph nodes can be extracted by this technique

  Two years

Study Arms (2)

patients for whom Complete mesocolic excision will be done

ACTIVE COMPARATOR

Procedure: Total Mesocolic Excision with Central Vessel Ligation

patients had conventional surgery before

ACTIVE COMPARATOR

Procedure: conventional surgery of cancer colon

Interventions

Total Mesocolic Excision with Central Vessel Ligation PROCEDURE

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.

patients for whom Complete mesocolic excision will be done

conventional surgery of cancer colon PROCEDURE

removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon

patients had conventional surgery before

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Mostafa A. Hassanein, professor

  Assiut University

  STUDY CHAIR

• Mohamed B. Kotb, profeesor

  Assiut University

  STUDY DIRECTOR

• Mahmoud T. Ahmed, lecturer

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Amr E. Hassan, resident Doctor

CONTACT

01004664295; amrelfayed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor At Assuit University Hospital

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 6, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 1, 2021
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL