Clinical trial NCT06924931: Five-year Recurrence After LCME
Official title: Five-year Recurrence and Postoperative Complications After Laparoscopic Complete Mesocolic Excision- a Population-Based, Multicentred Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer Stage I
Colon Cancer Stage II
Colon Cancer Stage III
Keywords: colon cancer
LCME
CME
recurrence
laparoscopic complete mesoclic excision
Lead sponsor: Gødstrup Hospital
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 2529
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence
timeFrame: From surgery to date of recurrence or end of 5-years follow up.
Secondary outcomes:
measure: mortality
timeFrame: From surgery to the date of mortality or end of 5-years follow-up.
measure: postoperative complications
timeFrame: 30 days after primary surgery
Other outcomes:
Locations:
Study officials:
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