TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection

NCT06528054 | Not Yet Recruiting

• 1 other identifier: 2024-3-2500
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives:

1. 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. 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

Outcome Measures

Primary Outcomes (2)

• 90-day mortality

  mortality correlated with anastomotic leakage

  90 days after colon cancer resection

• 90-day Clavien-Dindo grade IV - V complications

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

  90 days after colon cancer resection

Secondary Outcomes (7)

• Time from colon cancer resection to diagnosis of anastomotic leakage

  at least one year follow up

• Time from colon cancer resection to primary treatment of anastomotic leakage

  at least one year follow up

• Length of hospital/intensive care unit stay

  at least one year follow up

• Mortality

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

• Stoma presence (and if so, type of stoma)

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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."

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead

Related Publications (1)

• 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.

  PMID: 40375249 DERIVED

MeSH Terms

Conditions

Anastomotic Leak; Colonic Neoplasms

Interventions

Mortality

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Vital Statistics; Data Collection; Epidemiologic Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Hans de Wilt, Professor

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Pieter Tanis, Professor

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jobbe Lemmens, MD

CONTACT

00316 52331762; jobbe.lemmens@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07