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NCT Number: NCT06528054

TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

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

Primary outcomes

  1. 90-day mortality

    Time frame: 90 days after colon cancer resection

    mortality correlated with anastomotic leakage

  2. 90-day Clavien-Dindo grade IV - V complications

    Time frame: 90 days after colon cancer resection

    This composite co-primary outcome consists of single-organ failure (i.e. grade IV) and mortality (i.e. grade V)

Secondary outcomes

  1. Time from colon cancer resection to diagnosis of anastomotic leakage

    Time frame: at least one year follow up

  2. Time from colon cancer resection to primary treatment of anastomotic leakage

    Time frame: at least one year follow up

  3. Length of hospital/intensive care unit stay

    Time frame: at least one year follow up

  4. Mortality

    Time frame: 30-day, 90-day and one-year after colon cancer resection

  5. Stoma presence (and if so, type of stoma)

    Time frame: At least one year after colon cancer resection, preferably last date of follow up

  6. Disease status

    Time frame: At least one year after colon cancer resection, preferably at last date of follow up

  7. Number of radiologic and surgical reinterventions

    Time frame: One year after colon cancer resection

Study contacts

Contact information is provided by the study sponsor or research team.

Jobbe Lemmens, MD

CONTACT

[email protected]

00316 52331762

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection: the TENTACLE - Colon Study

Acronym: TENTACLE-Colon

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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