Evidence map›Paper›PMID 40375249›Full record

ArticleBMC surgery2025

TreatmENT of AnastomotiC LeakagE after colon cancer resection: the TENTACLE - Colon study.

Jobbe M G Lemmens, Sander Ubels, Nynke G Greijdanus, Kiedo Wienholts, Marleen M H J van Gelder, Albert Wolthuis, Jérémie H Lefevre, Kilian Brown, Matteo Frasson, Nicolas Rotholtz and 10 more

Registry-linked trialAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06528054 (TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06528054 unknown statusnot on this map

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

TypeobservationalSponsorRadboud University Medical CenterRan2024 to 2026Enrolled2,000ConditionsTreatment, Anastomotic Leakage, Resection, Colon CancerArmsDevelopment of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakage
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Jobbe M G LemmensDepartment of Surgery, Radboud University Medical Centre, Radboud Institute for Health Sciences, Nijmegen, the Netherlands. Jobbe.Lemmens@radboudumc.nl.
Sander UbelsDepartment of Surgery, Radboud University Medical Centre, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.
Nynke G GreijdanusDepartment of Surgery, Radboud University Medical Centre, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.
Kiedo WienholtsDepartment of Surgery, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands.
Marleen M H J van GelderIQ Health Science Department, Radboud University Medical Centre, Nijmegen, the Netherlands.
Albert WolthuisDepartment of Surgery, UZ Leuven, Leuven, Belgium.
Jérémie H LefevreDepartment of Digestive Surgery, Sorbonne Université, AP-HP, Hôpital Saint Antoine, Paris, France.
Kilian BrownDepartment of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, Australia.
Matteo FrassonDepartment of Surgery, Hospital La Fe, University of Valencia, Valencia, Spain.
Nicolas RotholtzDepartment of Surgery, Hospital Alemán, Buenos Aires, Argentina.
Quentin DenostBordeaux Colorectal Institute, Clinique Tivoli, Bordeaux, France.
Rodrigo O PerezColorectal Surgery, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.
Tsuyoshi KonishiDepartment of Colon and Rectal Surgery, The University of Texas MD Anderson Cancer Center, Anderson, Texas, USA.
Martin RutegårdDiagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.
Susan L GearhartDepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Thomas PinkneyAcademic Department of Surgery, University of Birmingham, Birmingham, UK.
Muhammed ElhadiFaculty of Medicine, University of Tripoli, Tripoli, Libya.
Roel HompesDepartment of Surgery, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands.
Pieter J Tanis *Department of Oncological and Gastrointestinal Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
Johannes H W de Wilt *Department of Surgery, Radboud University Medical Centre, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnastomotic leakage (AL) is a common and severe complication after colon cancer resection, but studies investigating various treatment strategies and factors influencing outcomes are scarce.

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 with subsequent development and validation of prediction models, and (2) to explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, adjusting for type of index surgery, different leak entities and patient factors.

methodsThe TENTACLE - Colon is an international multicentre retrospective cohort study. Consecutive patients with AL after colon cancer resection operated between 1 January 2018 and 31 December 2022 from participating centres will be included. The planned sample size is 2000 patients. The primary outcome is 90-day mortality and the co-primary composite endpoint is Clavien-Dindo grade 4-5 complications. Secondary outcomes include: hospital and intensive care unit length of stay, number of radiological and surgical reinterventions within one year after resection, mortality (in-hospital, 30-day, and 1-year), the comprehensive complication index, and 1-year stoma-free survival. For objective 1, regression models will be used to identify predictors associated with 90-day mortality and grade 4-5 complications. For objective 2, comparative analyses of various treatment strategies will be performed for the specified outcomes, adjusting for patient, tumour, resection and leakage characteristics.

trial registrationThis study is registered at clinicaltrials.gov (NCT06528054) since July 30th, 2024.

Indexed as

Anastomotic LeakColectomyColonic NeoplasmsAgedFemaleHumansMaleMiddle AgedRetrospective StudiesRisk FactorsAnastomotic leakageColon cancer resectionSeverityTreatment

Identifiers

PMID40375249
PMCPMC12082942

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.