Five-year Recurrence After LCME
Five-year Recurrence and Postoperative Complications After Laparoscopic Complete Mesocolic Excision- a Population-Based, Multicentred Study
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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PRE
pre-implementation group
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POST
post-implementation group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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From surgery to date of recurrence or end of 5-years follow up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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From surgery to the date of mortality or end of 5-years follow-up.
|
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postoperative complications
Time Frame: 30 days after primary surgery
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30-day postoperative complications
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30 days after primary surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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