Colorectal resection or stoma closure: Elective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure
Study summary
This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer.
The main questions to answer are:
* can these biomarkers predict anastomotic leakages
* can these biomarkers predict recurrence after colorectal cancer
* can these biomarkers be used as diagnostic tests for colorectal cancer
* can these biomarkers be identified in the tumor
Participants will undergo elective colorectal resection or stoma closure.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients diagnosed or with suspicion of colorectal cancer or adenoma, inflammatory bowel disease, late complications to colon diverticulosis, colostomy reversal or other diagnoses requiring colorectal resection.
* Patients planned to undergo elective surgical procedures coded as KJFB20-KJFB99, KJFG30-37 or KJGB00-97 according to the Danish modification of the NOMESCO Classification of Surgical Procedures
* Able to speak Danish, English, or other languages where professional interpretation is available
* Able to give informed consent
Exclusion Criteria:
* Patients undergoing synchronous: liver resection (patients undergoing metastasectomies can be included); total gastrectomy or cardia resection; Whipple's procedure or another major pancreatic resection (resections of the pancreatic tail can be included); total or partial nephrectomies or cystectomy
* Patients previously included in the study
* Patients known to be pregnant (pregnancy test not required)
* Non-resident in Denmark
Primary outcome measure(s)
Rate of anastomotic leakage diagnosed by CT-scan or reoperation — 30 days Anastomotic leakage after colorectal resection with anastomosis or stoma closure
Rate of major postoperative complications — 30 days Major postoperative complication (Clavien-Dindo score 3B or higher, and DVT and pulmonary embolism) after colorectal resection with anastomosis or stoma closure
Short-term mortality — 90 days Postoperative mortality after colorectal resection with anastomosis or stoma closure
Recurrence after colorectal cancer — 4 years Recurrence after radical resection, diagnosed by imaging modalities or tissue biopsy
Diagnostic value of omics and other biomarkers detecting colorectal cancer — 30 days Identifying omics and chondroitin sulfate-modified proteoglycans that can be used i a clinical setting to identify colorectal cancer patients
Correlation between biomarker in plasma and tissue — 30 days Does presence of tumor markers in blood plasma correlate with the same tumor makers in the tumor tissue
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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