TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection

Not yet recruiting

• Conditions: Anastomotic Leakage; Colon Cancer; Resection; Treatment

• Registration Number: NCT06528054
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Study Start: 2024-10
• Primary Completion: 2025-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
90-day mortality	90 days after colon cancer resection	mortality correlated with anastomotic leakage
90-day Clavien-Dindo grade IV - V complications	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 Outcome Measures

Name	Time	Method
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