Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Majano Díaz Lucía, Rodríguez de Santiago Enrique, Núñez Rodríguez Henar, Corte Daniel Pérez, de Jorge Turrión Miguel Ángel, Pellisé Maria, Ocón Julia Martínez, Pons Fausto Riu, Santiago García José, Alonso Eva Barreiro, Escaja Carlos Rodríguez, Santos Rodríguez Andrés, Cañete Ruiz Ángel, Muriel Alfonso, Zamora Javier, García Beatriz Peñas, Carbonell Sofía Parejo, García García de Paredes Ana, Garrido Gómez Elena, López Cardona Julia, Durán Sergio López, Aicart-Ramos Marta, Lalastra Carla Senosiaín, Ángel Rodríguez Gandía Miguel, García de la Filia Irene, Aldehuelo Rubén Sánchez, Hernández Eduardo Tavío, Martínez Sánchez Alba, Mateos Muñoz Beatriz, Martínez González Javier, Ortega Jesús Donate, de la Fuente Briongos Elsa, Redondo Pilar Díez, Cano Carolina Cerrella, Álvarez Leire Parapar, Pieter Carmen Elisa Caceres, Remizova Maria Ojeda, Gonzalez Silva Irene, Ferrer Blanco Ana, Claros Laura Sanroman, Tejedor-Tejada Javier, Jiménez Jurado Andrea, Mazzola Valeria Karina Calabuig, Cabal Ignacio Berdial, Leoz Diego, Rivas Eva, Calvo Andrea, Herreros-de-Tejada Alberto, de Frutos Rosa Diego, Gómez Fátima Valentín, Gutiérrez Landaluce Paula, Colomet Raquel Marcé, Díez Pablo Flórez, Blanco García Lorena, Castaño Fernández Olegario, Ruiz Zorrilla López Rafael, Lorenzo Marina Eliana Millán, López Fernández Eduardo, Sierra Morales María, García Centeno Pilar, Maestro Prada Isabel, Vázquez-Sequeiros Enrique, Albillos Martínez Agustín, Mucosal Resection and Third-Space Endoscopy SEED Working Group
Аннотация
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.