TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection (TENTACLE-Colon)

Radboud University Medical Center

Status: Not yet enrolling

Conditions: Treatment; Colon Cancer; Resection; Anastomotic Leakage

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

Study type: Observational

Funder types: Other

Identifiers

NCT06528054

2024-3-2500

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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."
• Regarding the type of colon cancer resection, the following patients will also fulfil the inclusion criteria: patients who underwent cytoreductive surgery (CRS) simultaneous with resection of the primary colon cancer with or without hyperthermic intraperitoneal chemotherapy (HIPEC), simultaneous ablations/resections of metastasis, multivisceral resection, emergency resection, patients diagnosed with perforated disease/peritumoral abscess or fistula, and acute obstructions.

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)