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Completed

NCT Number: NCT06924931

Five-year Recurrence After LCME

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed colon cancer patients.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Recurrence

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

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

Secondary outcomes

  1. mortality

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

    The cumulative incidence of mortality 5 years after surgery.

  2. postoperative complications

    Time frame: 30 days after primary surgery

    30-day postoperative complications

Sponsors and collaborators

Lead sponsor

Gødstrup Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2024
Study completion
2025
First posted
Apr 13, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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