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This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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Adult patients who developed AL after surgical resection with formation of primary anastomosis for colon cancer (cT1-4bN0-2M0-1).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jobbe Lemmens, MD | Contact | 00316 52331762 | jobbe.lemmens@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Hans de Wilt, Professor | Radboud University Medical Center | Principal Investigator |
| Pieter Tanis, Professor | Erasmus Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40375249 | Derived | 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. |
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Data may be available upon reasonable request. Only collaborators with appropriate qualifications and pertinent research inquiries are eligible to request access to the data. The principal investigators of the TENTACLE - Colon study will assess the relevance and appropriateness of the request and their verdict is decisive. If data will be transferred, it will solely be conducted under the appropriate ethical and data transfer agreement.
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
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| ID | Term |
|---|---|
| D009026 | Mortality |
| ID | Term |
|---|---|
| D014798 | Vital Statistics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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| 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 |
| Disease status | At least one year after colon cancer resection, preferably at last date of follow up |
| Number of radiologic and surgical reinterventions | One year after colon cancer resection |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003710 |
| Demography |
| D011154 | Population Characteristics |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |