Five-year Recurrence After LCME

NCT06924931 | Completed

• 1 other identifier: LapCMEinCDR
• Study Type: observational
• Target: 2,529
• Locations: 0 countries
• Sites: N/A

Brief Summary

A register-based study is conducted to examine clinical outcomes following a population-based, multi-centred implementation of Laparoscopic Complete Mesocolic Excision (LCME) in the Central Denmark Region, Denmark.

Conditions

Colon Cancer Stage II; Colon Cancer Stage III; Colon Cancer Stage I

Keywords

colon cancer; LCME; CME; recurrence; laparoscopic complete mesoclic excision

Outcome Measures

Primary Outcomes (1)

• Recurrence

  The cumulative incidence of colon cancer recurrence 5 years after surgery.

  From surgery to date of recurrence or end of 5-years follow up.

Secondary Outcomes (2)

• mortality

  From surgery to the date of mortality or end of 5-years follow-up.

• postoperative complications

  30 days after primary surgery

Study Arms (2)

PRE

pre-implementation group

POST

post-implementation group

Behavioral: LCME training programme

Interventions

LCME training programme BEHAVIORAL

A LCME training program was conducted from March 2017 to October 2017 in the CDR, inspired by the National English Laparoscopic Colorectal Surgery Course. All certified colorectal surgeons from three public hospitals in the CDR were invited. The training programme was conducted over 2-3 days, occurring twice within an 8-month period.

POST

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included all colon cancer patients undergoing a curative-intent bowel resection in Central Denmark Region, Denmark in the following timeframe: (January 1, 2015-December 31, 2016) and (January 1, 2018-December 31, 2019).

You may qualify if:

• newly diagnosed colon cancer patients.

You may not qualify if:

• another synchronous colon cancer
• metastatic disease at the time of surgery
• non-curative procedures or local resections only
• Danish residency \<10 years preoperatively
• non-colon primary cancer.

Sponsors & Collaborators

• Gødstrup Hospital: lead

MeSH Terms

Conditions

Colonic Neoplasms; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: April 13, 2025
• Study Start: January 1, 2015
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share