Clinical trial NCT06528054: TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection
Official title: TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection: the TENTACLE - Colon Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Treatment
Anastomotic Leakage
Resection
Colon Cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who developed AL after surgical resection with formation of primary anastomosis for colon cancer (cT1-4bN0-2M0-1).

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.


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."
* 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)

Primary outcomes:
measure: 90-day mortality
timeFrame: 90 days after colon cancer resection
measure: 90-day Clavien-Dindo grade IV - V complications
timeFrame: 90 days after colon cancer resection
Secondary outcomes:
measure: Time from colon cancer resection to diagnosis of anastomotic leakage
timeFrame: at least one year follow up
measure: Time from colon cancer resection to primary treatment of anastomotic leakage
timeFrame: at least one year follow up
measure: Length of hospital/intensive care unit stay
timeFrame: at least one year follow up
measure: Mortality
timeFrame: 30-day, 90-day and one-year after colon cancer resection
measure: Stoma presence (and if so, type of stoma)
timeFrame: At least one year after colon cancer resection, preferably last date of follow up
measure: Disease status
timeFrame: At least one year after colon cancer resection, preferably at last date of follow up
measure: Number of radiologic and surgical reinterventions
timeFrame: One year after colon cancer resection
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Hans de Wilt, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Pieter Tanis, Professor
role: PRINCIPAL_INVESTIGATOR
References: