Open this publication in new window or tab >>IQ Health Science Department, Radboud University Medical Centre, Nijmegen, Netherlands.
Department of Surgery, UZ Leuven, Leuven, Belgium.
Department of Digestive Surgery, Sorbonne Université, AP-HP, Hôpital Saint Antoine, Paris, France.
Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, Australia.
Department of Surgery, Hospital La Fe, University of Valencia, Valencia, Spain.
Department of Surgery, Hospital Alemán, Buenos Aires, Argentina.
Bordeaux Colorectal Institute, Clinique Tivoli, Bordeaux, France.
Colorectal Surgery, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil; Department of Surgery, Hospital Beneficência Portuguesa de São Paulo, São Paulo, Brazil.
Department of Colon and Rectal Surgery, The University of Texas MD Anderson Cancer Center, TX, Anderson, United States.
Umeå University, Faculty of Medicine, Department of Diagnostics and Intervention.
Department of Surgery, Johns Hopkins University School of Medicine, MD, Baltimore, United States.
Academic Department of Surgery, University of Birmingham, Birmingham, United Kingdom.
Faculty of Medicine, University of Tripoli, Tripoli, Libya.
Department of Surgery, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, Netherlands; Cancer Centre Amsterdam, Treatment and Quality of Life, Amsterdam, Netherlands; Cancer Centre Amsterdam, Imaging and Biomarkers, Amsterdam, Netherlands.
Department of Oncological and Gastrointestinal Surgery, Erasmus Medical Centre, Rotterdam, Netherlands.
Department of Surgery, Radboud University Medical Centre, Radboud Institute for Health Sciences, Nijmegen, Netherlands.
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2025 (English)In: BMC Surgery, E-ISSN 1471-2482, Vol. 25, no 1, article id 213Article in journal (Refereed) Published
Abstract [en]
Background: Anastomotic 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.
Methods: The 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 registration: This study is registered at clinicaltrials.gov (NCT 06528054) since July 30th, 2024.
Place, publisher, year, edition, pages
BioMed Central (BMC), 2025
Keywords
Anastomotic leakage, Colon cancer resection, Severity, Treatment
National Category
Surgery
Identifiers
urn:nbn:se:umu:diva-239178 (URN)10.1186/s12893-025-02954-1 (DOI)001489559200005 ()40375249 (PubMedID)2-s2.0-105005261044 (Scopus ID)
2025-06-052025-06-052025-06-05Bibliographically approved