Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM
Abstrak
Background Colorectal polypectomy plays a crucial role in reducing mortality from colorectal cancer. Postpolypectomy bleeding is the most common adverse event. Current European guidelines recommend a temporary suspension of anticoagulation for polypectomy, despite the lack of high-quality evidence supporting this practice. Recent data challenge this approach, suggesting that polypectomy without discontinuing anticoagulation is not only safe but may also reduce the incidence of thromboembolic events.Methods and analysis This multicentre, prospective randomised, endoscopist-blinded, investigator-initiated, non-inferiority clinical trial aims to compare the safety of temporary interruption versus maintenance of anticoagulation during polypectomy for colorectal lesions. A total of 481 patients on oral anticoagulant treatment (either vitamin K antagonists or direct oral anticoagulants), and scheduled for an elective colonoscopy for any indication, will be randomised in a 1:1 ratio to each group. Colonoscopy and polypectomy procedures will be conducted by experienced endoscopists at 11 Spanish hospitals. The primary outcome is clinically significant postpolypectomy haemorrhage, while the secondary outcomes involve evaluating the risk of thromboembolic events and other procedural-related variables. Non-inferiority will be assessed in the per-protocol population using an adjusted absolute risk difference margin of 10%.Ethics and dissemination The study protocol was initially approved by the Medical Ethics Committee of Hospital Clínico San Carlos, Madrid, Spain (approval number: 24/330-EC_M). According to Spanish legislation on clinical trials, approval by a single CEIm is sufficient for multicentre studies and is recognised by all participating centres. The decision of the approving ethics committee is therefore applicable to all study sites. All participants will provide written informed consent prior to enrolment.The results of this study will be disseminated through publication in a peer-reviewed scientific journal and presentation at relevant national and international gastroenterology and endoscopy conferences.Trial registration number NCT07185295.
Topik & Kata Kunci
Penulis (63)
Andrea Calvo
María Pellisé
Alfonso Muriel
Enrique Vazquez-Sequeiros
Javier Zamora
Ana Garcia Garcia de Paredes
Eva Rivas
Javier Martínez Gonzalez
Javier Tejedor-Tejada
Enrique Rodríguez de Santiago
Eduardo López Fernández
Lucía Majano Díaz
Henar Núñez Rodríguez
Daniel Pérez Corte
Miguel Ángel de Jorge Turrión
Julia Martínez Ocón
Fausto Riu Pons
José Santiago García
Eva Barreiro Alonso
Carlos Rodríguez Escaja
Andrés Santos Rodríguez
Ángel Cañete Ruiz
Beatriz Peñas García
Sofía Parejo Carbonell
Elena Garrido Gómez
Julia López Cardona
Sergio López Durán
Marta Aicart-Ramos
Carla Senosiaín Lalastra
Miguel Ángel Rodríguez Gandía
Irene García de la Filia
Rubén Sánchez Aldehuelo
Eduardo Tavío Hernández
Alba Martínez Sánchez
Beatriz Mateos Muñoz
Jesús Donate Ortega
Elsa de la Fuente Briongos
Pilar Díez Redondo
Carolina Cerrella Cano
Leire Parapar Álvarez
Carmen Elisa Caceres Pieter
Maria Ojeda Remizova
Irene Gonzalez Silva
Ana Ferrer Blanco
Laura Sanroman Claros
Andrea Jiménez Jurado
Valeria Karina Calabuig Mazzola
Ignacio Berdial Cabal
Diego Leoz
Alberto Herreros-de-Tejada
Diego de Frutos Rosa
Fátima Valentín Gómez
Paula Gutiérrez Landaluce
Raquel Marcé Colomet
Pablo Flórez Díez
Lorena Blanco García
Olegario Castaño Fernández
Rafael Ruiz Zorrilla López
Marina Eliana Millán Lorenzo
María Sierra Morales
Pilar García Centeno
Isabel Maestro Prada
Agustín Albillos Martínez
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PDF tidak tersedia langsung
Cek di sumber asli →- Tahun Terbit
- 2026
- Sumber Database
- DOAJ
- DOI
- 10.1136/bmjopen-2025-111695
- Akses
- Open Access ✓