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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04079946
Other study ID # AssiutU93
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date June 1, 2021

Study information

Verified date September 2019
Source Assiut University
Contact Amr E. Hassan, resident Doctor
Phone 01004664295
Email amrelfayed@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date June 1, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
conventional surgery of cancer colon
removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Lymph nodes harvest Number of retrieved lymph nodes can be extracted by this technique Two years
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