Five-year Recurrence After LCME

Five-year Recurrence and Postoperative Complications After Laparoscopic Complete Mesocolic Excision- a Population-Based, Multicentred Study

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.

Study Overview

• Status: Completed
• Conditions: Colon Cancer Stage II; Colon Cancer Stage I; Colon Cancer Stage III
• Intervention / Treatment: Behavioral: LCME training programme

Detailed Description

This study was conducted as a population-based "before-and-after" cohort study following the implementation of LCME in the Central Denmark Region (CDR), Denmark, in 2017. The IDEAL framework (Idea, Development, Evaluation, Assessment, Long-term) was used for examining the outcome of a training program on the LCME adoption.

Training programme A LCME training program was conducted from March 2017 to October 2017 in the CDR, inspired by the National English Laparoscopic Colorectal Surgery Course.

Patients This study included all colon cancer patients undergoing a curative-intent bowel resection in the defined timeframe. Exclusion criteria comprised: 1) another synchronous colon cancer; 2) metastatic disease at the time of surgery; 3) non-curative procedures or local resections only; 4) Danish residency <10 years preoperatively; and 5) non-colon primary cancer.

Data sources The DCCG database, a national registry of newly diagnosed colon cancer patients, was used to identify the primary cohort. For follow-up data beyond 30 days after surgery, the cohort was linked to the following registries: 1) the Danish Civil Registration System (DCRS), 2) the Danish Cancer Registry (DCR), 3) the Danish National Patient Registry (DNPR), 4) the Danish Pathology Registry (DPR) and the Danish Pathological Data Bank (DPDB).

Outcome The primary outcome was the cumulative incidence of colon cancer recurrence 5 years after surgery. A validated algorithm was used to identify recurrence.

The secondary outcome was postoperative complications within 30 days graded by the Clavien- Dindo Classification (CDC) (minor: I-II, major: III-V).

• Study Type: Observational
• Enrollment (Actual): 2529

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

• newly diagnosed colon cancer patients.

Exclusion Criteria:

1. another synchronous colon cancer
2. metastatic disease at the time of surgery
3. non-curative procedures or local resections only
4. Danish residency <10 years preoperatively
5. non-colon primary cancer.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PRE; pre-implementation group
POST; post-implementation group	Behavioral: LCME training programme; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	The cumulative incidence of mortality 5 years after surgery.	From surgery to the date of mortality or end of 5-years follow-up.
postoperative complications	30-day postoperative complications	30 days after primary surgery

Collaborators and Investigators

• Sponsor: Gødstrup Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: April 5, 2025
• First Submitted That Met QC Criteria: April 5, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: colon cancer; recurrence; CME; LCME; laparoscopic complete mesoclic excision
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Recurrence; Colonic Neoplasms
• Other Study ID Numbers: LapCMEinCDR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared as this is a register-based study, and according to the GLPR and Danish law, the IPD date cannot be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No