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Clinical Trials/NCT06528054
NCT06528054
Not yet recruiting
Not Applicable

TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection: the TENTACLE - Colon Study

Radboud University Medical Center0 sites2,000 target enrollmentStarted: October 2024Last updated:
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ConditionsTreatmentAnastomotic LeakageResectionColon Cancer

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
2,000
Primary Endpoint
90-day mortality
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives:

  1. To identify predictive factors associated with 90-day mortality and 90-day Clavien-Dindo grade 4-5 complications amongst patients who developed AL following colon cancer resection and to develop and validate a prediction model for predicting 90-day mortality as well as the co-primary composite endpoint Clavien-Dindo grade 4-5 complications.
  2. To explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, considering patient, tumour, resection and leakage characteristics.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

90-day mortality

Time Frame: 90 days after colon cancer resection

mortality correlated with anastomotic leakage

90-day Clavien-Dindo grade IV - V complications

Time Frame: 90 days after colon cancer resection

This composite co-primary outcome consists of single-organ failure (i.e. grade IV) and mortality (i.e. grade V)

Secondary Outcomes

  • Length of hospital/intensive care unit stay(at least one year follow up)
  • Mortality(30-day, 90-day and one-year after colon cancer resection)
  • Time from colon cancer resection to diagnosis of anastomotic leakage(at least one year follow up)
  • Stoma presence (and if so, type of stoma)(At least one year after colon cancer resection, preferably last date of follow up)
  • Disease status(At least one year after colon cancer resection, preferably at last date of follow up)
  • Time from colon cancer resection to primary treatment of anastomotic leakage(at least one year follow up)
  • Number of radiologic and surgical reinterventions(One year after colon cancer resection)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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