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NCT04395534 Clinical Trial

Non-microradical Resection Margin as a Predictor for Recurrence After Complete Mesocolic Excision

Colon Cancer Clinical Trial

Official title:
Non-microradical Resection Margin as a Predictor for Recurrence After Complete Mesocolic Excision: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04395534
Other study ID # R1 - CME
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2008
Est. completion date March 15, 2020

Study information
Verified date May 2020
Source Nordsjaellands Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aim to investigate the value of the current definition of microradical resection margin in colon cancer. Is the distance from tumor tissue to resection margin and the site of any clinically prognostic importance if complete mesocolic excision has been performed.

Recruitment information / eligibility
Status Completed
Enrollment 276
Est. completion date March 15, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Undergoing elective curative intended complete mesocolic excision for primary colon adenocarcinoma at Nordsjællands Hospital in Hillerød, Denmark

- International Union Against Cancer (Union Internationale Contre le Cancer - UICC) stage III - pT1-4, pN1-2 cM0 (gastroepiploic and infrapyloric lymph node metastases are not considered as distant metastases)

- Resident in Denmark at the time of surgery.

Exclusion Criteria:

- Patients who did not undergo macroradical resections

- Synchronous colorectal cancer

- Venous invasion at central venous ligation.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Complete mesocolic excision

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Claus Anders Bertelsen, PhD, MD

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence Any type of recurrence 3 years
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