Colon Cancer Stage INCT06924931
Five-year Recurrence After LCME
An observational study of Colon Cancer Stage I and Colon Cancer Stage II, run by Gødstrup Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer Stage I, Colon Cancer Stage II, Colon Cancer Stage III
- What is being tested?
- LCME training programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,529 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Feb 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- newly diagnosed colon cancer patients.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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).
- Being tested
- LCME training programme
- Keywords
- colon cancer, LCME, CME, recurrence, laparoscopic complete mesoclic excision
- Medical subject headings
- Colonic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCME training programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PRE | pre-implementation group | |
| POST | post-implementation group Receives: Behavioral: LCME training programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
The cumulative incidence of colon cancer recurrence 5 years after surgery.
Measured: From surgery to date of recurrence or end of 5-years follow up.
Secondary outcomes (2)
mortality
The cumulative incidence of mortality 5 years after surgery.
Measured: From surgery to the date of mortality or end of 5-years follow-up.
postoperative complications
30-day postoperative complications
Measured: 30 days after primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Jan 2015
- Primary completion31 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,529 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924931
- Sponsor's protocol ID
- LapCMEinCDR
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-year Recurrence and Postoperative Complications After Laparoscopic Complete Mesocolic Excision- a Population-Based, Multicentred Study
- ClinicalTrials.gov ID
- NCT06924931
- Acronym / sponsor ID
- LapCMEinCDR
- Keywords
- colon cancer, LCME, CME, recurrence, laparoscopic complete mesoclic excision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,529 participants (actual)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRE | – | –pre-implementation group |
| POST | – | Behavioral: LCME training programmepost-implementation group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- newly diagnosed colon cancer patients.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCME training programmeA 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. | Behavioural | POST |
Primary outcome
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.
2 secondary outcomes
mortality
Time frame: From surgery to the date of mortality or end of 5-years follow-up.
postoperative complications
Time frame: 30 days after primary surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer Stage I and Colon Cancer Stage II, run by Gødstrup Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: From surgery to date of recurrence or end of 5-years follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.