Health TrialsbyHealthPanel

Colorectal Omics and OfCS Proteoglycans

ConditionsColorectal CancerDiverticulitis, ColonicInflammatory Bowel DiseasesStoma Colostomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClaus Anders Bertelsen, PhD, MD

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients planned for elective colorectal surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Colorectal resection or stoma closure

    Procedure/Surgery

    Elective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Study cohort1 intervention

Trial outcomes

Primary outcomes

1

Rate of anastomotic leakage diagnosed by CT-scan or reoperation

Anastomotic leakage after colorectal resection with anastomosis or stoma closure

Time frame
30 days
2

Rate of major postoperative complications

Major postoperative complication (Clavien-Dindo score 3B or higher, and DVT and pulmonary embolism) after colorectal resection with anastomosis or stoma closure

Time frame
30 days
3

Short-term mortality

Postoperative mortality after colorectal resection with anastomosis or stoma closure

Time frame
90 days
4

Recurrence after colorectal cancer

Recurrence after radical resection, diagnosed by imaging modalities or tissue biopsy

Time frame
4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Claus Anders Bertelsen, PhD, MD

Lead sponsor

Nordsjaellands Hospital

Sponsor institution

Viborg Regional Hospital

Collaborator

Source ClinicalTrials.gov
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