Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528054
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection the TENTACLE - Colon Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENTACLE-Colon
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None