TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection

NCT ID: NCT06528054

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2026-03-31

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.

Conditions

Treatment; Anastomotic Leakage; Resection; Colon Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Development of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakage

The prediction model and comparison of various treatment strategies will be studies when the data is available for analysis.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older;
• Surgical resection for primary colon cancer (cT1-4b, N0-2, M0-1) with formation of a primary colonic anastomosis and with or without diverting stoma;
• Postoperative AL defined as: "any clinical, radiological or intraoperative signs of disrupted integrity of the anastomosis. This also includes suspected leaks with any degree of extraluminal air or fluid on CT, perianastomotic abscess, purulent peritonitis without clear anastomotic defect, or any other suspicious condition in which there is no ultimate macroscopic proof of disrupted anastomosis."

Exclusion Criteria

• Surgical resection for benign colon disease;
• Recurrent colon cancer resection;
• Any primary colon malignancy other than adenocarcinoma (e.g. neuroendocrine tumour, gastrointestinal stromal tumour);
• Any clinical condition that does not fulfil the broad definition of AL as used in this study (e.g. only free air on CT that is considered to be compatible with an appropriate postoperative day in the absence of any other clinical signs related to a potential anastomotic leakage)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans de Wilt, Professor

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Pieter Tanis, Professor

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Central Contacts

Jobbe Lemmens, MD

Role: CONTACT

jobbe.lemmens@radboudumc.nl

00316 52331762

References

Lemmens JMG, Ubels S, Greijdanus NG, Wienholts K, van Gelder MMHJ, Wolthuis A, Lefevre JH, Brown K, Frasson M, Rotholtz N, Denost Q, Perez RO, Konishi T, Rutegard M, Gearhart SL, Pinkney T, Elhadi M, Hompes R, Tanis PJ, de Wilt JHW. TreatmENT of AnastomotiC LeakagE after colon cancer resection: the TENTACLE - Colon study. BMC Surg. 2025 May 15;25(1):213. doi: 10.1186/s12893-025-02954-1.

Reference Type: DERIVED

PMID: 40375249 (View on PubMed)

Other Identifiers

2024-3-2500

Identifier Type: -

Identifier Source: org_study_id