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

• Sponsor: Claus Anders Bertelsen, PhD, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT04395534
• Collaborator: (none)
• Enrollment: 276
• Actual Duration (Months): 141.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Procedure: Complete mesocolic excision

Study Design

• Study Type: Observational
• Actual Enrollment: 276 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-microradical Resection Margin as a Predictor for Recurrence After Complete Mesocolic Excision: a Prospective Cohort Study
• Actual Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Mar 15, 2020
• Actual Study Completion Date: Mar 15, 2020

Outcome Measures

Primary Outcome Measures

1. Recurrence [3 years]

   Any type of recurrence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Claus Anders Bertelsen, PhD, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Claus Anders Bertelsen, PhD, MD, Consultant Colorectal Surgeon, Associate Professor, Head of Research Department of Surgery, Nordsjaellands Hospital
• ClinicalTrials.gov Identifier: NCT04395534
• Other Study ID Numbers: R1 - CME
• First Posted: May 20, 2020
• Last Update Posted: May 20, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Recurrence

Study Results

No Results Posted as of May 20, 2020