Status:
NOT_YET_RECRUITING
TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection
Lead Sponsor:
Radboud University Medical Center
Conditions:
Treatment
Anastomotic Leakage
Eligibility:
All Genders
18+ years
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 w...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06528054
Start Date
October 1 2024
End Date
March 1 2026
Last Update
July 30 2024
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