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

NCT ID: NCT04079946

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients for whom Complete mesocolic excision will be done

Group Type: ACTIVE_COMPARATOR

Total Mesocolic Excision with Central Vessel Ligation

Intervention Type: 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 had conventional surgery before

Group Type: ACTIVE_COMPARATOR

conventional surgery of cancer colon

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

conventional surgery of cancer colon

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amr Essam Hassan Farghly

Resident Doctor At Assuit University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mostafa A. Hassanein, professor

Role: STUDY_CHAIR

Assiut University

Mohamed B. Kotb, profeesor

Role: STUDY_DIRECTOR

Assiut University

Mahmoud T. Ahmed, lecturer

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Amr E. Hassan, resident Doctor

Role: CONTACT

amrelfayed@gmail.com

01004664295

Other Identifiers

AssiutU93

Identifier Type: -

Identifier Source: org_study_id