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Five-year Recurrence After LCME

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06924931
Enrollment
2529
Registered
2025-04-13
Start date
2015-01-01
Completion date
2025-02-01
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer Stage I, Colon Cancer Stage II, Colon Cancer Stage III

Keywords

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

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.

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).

Interventions

BEHAVIORALLCME 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.

Sponsors

Gødstrup Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
RecurrenceFrom surgery to date of recurrence or end of 5-years follow up.The cumulative incidence of colon cancer recurrence 5 years after surgery.

Secondary

MeasureTime frameDescription
mortalityFrom surgery to the date of mortality or end of 5-years follow-up.The cumulative incidence of mortality 5 years after surgery.
postoperative complications30 days after primary surgery30-day postoperative complications

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026