{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Lucía Majano Díaz"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Enrique Rodríguez de Santiago"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Río Hortega, Valladolid, Spain"
      ],
      "name": "Henar Núñez Rodríguez"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario San Agustín, Aviles, Spain"
      ],
      "name": "Daniel Pérez Corte"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Hospital Universitario de Cabueñes, Gijón, Spain"
      ],
      "name": "Miguel Ángel de Jorge Turrión"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Clínic Barcelona, Barcelona, Spain"
      ],
      "name": "Maria Pellisé"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Hospital Clinic de Barcelona, Barcelona, Spain"
      ],
      "name": "Julia Martínez Ocón"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital del Mar, Barcelona, Spain"
      ],
      "name": "Fausto Riu Pons"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Spain"
      ],
      "name": "José Santiago García"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain"
      ],
      "name": "Eva Barreiro Alonso"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Sierrallana, Torrelavega, Spain"
      ],
      "name": "Carlos Rodríguez Escaja"
    },
    {
      "affiliations": [
        "Gastroenterology, Hospital Universitario Principe de Asturias, Alcala de Henares, Spain"
      ],
      "name": "Andrés Santos Rodríguez"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Clínica Rotger Quirónsalud, Palma, Spain"
      ],
      "name": "Ángel Cañete Ruiz"
    },
    {
      "affiliations": [
        "Biostatistics Unit. IRYCIS. CIBERESP, Hospital Universitario Ramón y Cajal, Madrid, Spain",
        "Department of Medicine, Universidad de Alcalá, Alcala de Henares, Spain"
      ],
      "name": "Alfonso Muriel"
    },
    {
      "affiliations": [
        "Biostatistics Unit. IRYCIS. CIBERESP, Hospital Universitario Ramón y Cajal, Madrid, Spain"
      ],
      "name": "Javier Zamora"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Beatriz Peñas García"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Sofía Parejo Carbonell"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Ana García García de Paredes"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Elena Garrido Gómez"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Julia López Cardona"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Sergio López Durán"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Marta Aicart-Ramos"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Carla Senosiaín Lalastra"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Miguel Ángel Rodríguez Gandía"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Irene García de la Filia"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain",
        "Department of Medicine, Universidad de Alcalá, Alcala de Henares, Spain"
      ],
      "name": "Rubén Sánchez Aldehuelo"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Eduardo Tavío Hernández"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Alba Martínez Sánchez"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Beatriz Mateos Muñoz"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Javier Martínez González"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Jesús Donate Ortega"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Elsa de la Fuente Briongos"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Río Hortega, Valladolid, Spain"
      ],
      "name": "Pilar Díez Redondo"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario San Agustín, Aviles, Spain"
      ],
      "name": "Carolina Cerrella Cano"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario San Agustín, Aviles, Spain"
      ],
      "name": "Leire Parapar Álvarez"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario San Agustín, Aviles, Spain"
      ],
      "name": "Carmen Elisa Caceres Pieter"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario San Agustín, Aviles, Spain"
      ],
      "name": "Maria Ojeda Remizova"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario San Agustín, Aviles, Spain"
      ],
      "name": "Irene Gonzalez Silva"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario San Agustín, Aviles, Spain"
      ],
      "name": "Ana Ferrer Blanco"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital San Agustin de Aviles, Aviles, Spain"
      ],
      "name": "Laura Sanroman Claros"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario de Cabueñes, Gijón, Spain"
      ],
      "name": "Javier Tejedor-Tejada"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Hospital Universitario de Cabueñes, Gijón, Spain"
      ],
      "name": "Andrea Jiménez Jurado"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Hospital Universitario de Cabueñes, Gijón, Spain"
      ],
      "name": "Valeria Karina Calabuig Mazzola"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Hospital Universitario de Cabueñes, Gijón, Spain"
      ],
      "name": "Ignacio Berdial Cabal"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Hospital Clinic de Barcelona, Barcelona, Spain"
      ],
      "name": "Diego Leoz"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Hospital Clinic de Barcelona, Barcelona, Spain"
      ],
      "name": "Eva Rivas"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Hospital Clinic de Barcelona, Barcelona, Spain"
      ],
      "name": "Andrea Calvo"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Spain"
      ],
      "name": "Alberto Herreros-de-Tejada"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Spain"
      ],
      "name": "Diego de Frutos Rosa"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Spain"
      ],
      "name": "Fátima Valentín Gómez"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Spain"
      ],
      "name": "Paula Gutiérrez Landaluce"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Spain"
      ],
      "name": "Raquel Marcé Colomet"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain"
      ],
      "name": "Pablo Flórez Díez"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain"
      ],
      "name": "Lorena Blanco García"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain"
      ],
      "name": "Olegario Castaño Fernández"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Sierrallana, Torrelavega, Spain"
      ],
      "name": "Rafael Ruiz Zorrilla López"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Sierrallana, Torrelavega, Spain"
      ],
      "name": "Marina Eliana Millán Lorenzo"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Sierrallana, Torrelavega, Spain"
      ],
      "name": "Eduardo López Fernández"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Principe de Asturias, Alcala de Henares, Spain"
      ],
      "name": "María Sierra Morales"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hospital Universitario Principe de Asturias, Alcala de Henares, Spain"
      ],
      "name": "Pilar García Centeno"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Clínica Rotger Quirónsalud, Palma, Spain"
      ],
      "name": "Isabel Maestro Prada"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain"
      ],
      "name": "Enrique Vázquez-Sequeiros"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain",
        "Department of Medicine, Universidad de Alcalá, Alcala de Henares, Spain"
      ],
      "name": "Agustín Albillos Martínez"
    },
    {
      "affiliations": [],
      "name": "Mucosal Resection and Third-Space Endoscopy SEED Working Group"
    }
  ],
  "title": "Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM",
  "uid": "0f66cb1b-f375-5d73-888d-51063ddbfb0e"
}