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Predictive Factors for Anastomotic Leakage After Colorectal Surgery

NCT02347735 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 774

Last updated 2021-09-29

No results posted yet for this study

Summary

Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide, estimated to be responsible for almost 610,000 deaths in 2008. Surgery remains the predominant curative treatment type for colorectal cancer, but has a major impact on the patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the development of frequently observed and severe postoperative complications. The most important complication after colorectal surgery is anastomotic leakage (AL), which has an incidence of 8-15% in the Netherlands. AL is associated with high short-term mortality rates of up to 40%. Even though many attempts have been made to reduce the incidence of this dreaded complication, none of these interventions have been successful so far. Despite proper patient selection and improvement in surgical techniques, the percentage of AL has been stable for years.

Objectives: To investigate whether recently identified patient-specific factors can predict the occurrence of anastomotic leakage in patients undergoing elective surgery for colorectal cancer.

Study design: Prospective observational study Study population: Adult colorectal cancer patients undergoing elective surgery. Main study parameters/endpoints: Primary endpoint: AL within 30 days postoperatively Secondary endpoints: Intestinal microbiome in fecal sample, I-FABP, SM22, Calprotectin, C-reactive protein(CRP), Citrullin, complement factors in blood, VOCs in exhaled air, COX-2 \& MBL polymorphisms in buccal smear, L3-index \& atherosclerosis measurements on CT-scans, SNAQ \& MUST scores

Conditions

  • Anastomotic Leakage
  • Colorectal Cancer
  • Anastomotic Leak
  • Colorectal Neoplasms
  • Colorectal Carcinoma
  • Colorectal Tumors

Interventions

OTHER

No interventions, only data collection

Only data is collected from the subjects in both groups.

Sponsors & Collaborators

  • Zuyderland Medical Centre

    collaborator OTHER

  • VieCuri Medical Centre

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Nicole Bouvy, MD, PhD · Maastricht University Medical Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2021-07-01
Completion
2021-07-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02347735 on ClinicalTrials.gov