Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to find out if it is safe to keep taking blood-thinning medicine during the removal of polyps from the colon or rectum.
It includes patients who regularly take blood thinners and need an elective colonoscopy.
The main goal is to see how often patients have serious bleeding after the polyp removal within 30 days.
The study is being done in several hospitals, and doctors evaluating the results do not know which treatment patients receive.
This multicenter, phase IV, assessor-blinded, non-inferiority clinical trial evaluates the safety of maintaining oral anticoagulant therapy during colorectal polypectomy. The study population includes patients receiving chronic oral anticoagulation treatment with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) who are scheduled for elective colonoscopy for any indication.
The primary objective is to assess the incidence of clinically significant post-polypectomy bleeding within 30 days after the procedure. The trial tests the hypothesis that continuing anticoagulant therapy during polypectomy is non-inferior to interrupting it, with a non-inferiority margin set at 10%.
A total of 481 patients will be enrolled, with 241 patients per group. The intervention consists of maintaining ongoing anticoagulant treatment without modification before the procedure. This trial is classified as a low-intervention study according to regulatory guidelines and aims to provide evidence to optimize the management of anticoagulated patients undergoing colorectal polypectomy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintained Anticoagulant Therapy | Experimental | Patients in this treatment group will continue their anticoagulant therapy during the procedure. For those on vitamin K antagonists (VKAs), INR levels will be checked 7-14 days before the endoscopy, and doses adjusted if necessary to maintain therapeutic range (<3.5) before the procedure. Patients on direct oral anticoagulants (DOACs) will skip only the morning dose on the day of the procedure without other changes. |
|
| Discontinued Anticoagulant Therapy | No Intervention | In patients assigned to this treatment arm, anticoagulation will be temporarily discontinued following the recommendations of the 2021 BSG-ESGE clinical practice guideline. The distinction between high and low thrombotic risk will be made according to guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| To maintain anticoagulant therapy during the polypectomy of colorectal lesions | Procedure | Group A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant intraprocedural bleeding | Major bleeding during colonoscopy that requires procedure interruption, a drop in hemoglobin >2 g/dL, blood transfusion, interventional radiology, hospitalization, surgery, or results in death. The following data will be collected for bleeding events:
| 1 month |
| Clinically significant delayed hemorrhage | Gastrointestinal bleeding occurring within 30 days after completion of the colonoscopy that requires an emergency visit, hospitalization, or an intervention. Date of the event. - Length of hospital stay: Quantitative nominal variable. Unit: days. - ICU admission: Binary variable (Yes/No). - Severity: Assessed according to the ASGE classification. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Myocardial Infarction | A clinical syndrome characterized by evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Data collected will include event date, hospital stay duration, and ICU stay duration. | 1 month |
| Hospitalization for Unstable Angina |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Age over 85 years.
Urgent colonoscopy.
Labile INR (time in therapeutic range less than 60%) documented in the previous 3 months in patients receiving VKAs.
Supratherapeutic INR (>3.5) at the time of the procedure in patients on VKAs.
Pregnancy.
Decompensated liver cirrhosis.
Inability, at the investigator's discretion, to understand the periprocedural anticoagulation regimen.
Known coagulopathy or bleeding diathesis, including platelet count <50,000/µl in the previous 12 months.
Scheduled endoscopic dilation.
Severe psychiatric disorder.
Removal of colorectal lesions by endoscopic submucosal dissection.
Previous diagnosis of renal failure defined as creatinine >2 mg/dl or clearance <30 ml/min.
Planned high bleeding risk procedure during simultaneous gastroscopy.
Previous inclusion in the trial. Patients may only be included once.
Patients who are not candidates for a second endoscopic intervention due to clinical conditions.
Any clinical situation or concomitant treatment that, in the investigator's opinion, poses a significant bleeding risk.
Patients with polyps larger than 4 cm pending endoscopic resection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Rotger Quirónsalud | Palma | Balearic Islands | 07012 | Spain | ||
| Servicio de Aparato Digestivo. Hospital Sierrallana. Barrio Ganzo, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41916623 | Derived | Majano Diaz L, Rodriguez de Santiago E, Nunez Rodriguez H, Corte DP, de Jorge Turrion MA, Pellise M, Ocon JM, Pons FR, Santiago Garcia J, Alonso EB, Escaja CR, Santos Rodriguez A, Canete Ruiz A, Muriel A, Zamora J, Garcia BP, Carbonell SP, Garcia Garcia de Paredes A, Garrido Gomez E, Lopez Cardona J, Duran SL, Aicart-Ramos M, Lalastra CS, Angel Rodriguez Gandia M, Garcia de la Filia I, Aldehuelo RS, Hernandez ET, Martinez Sanchez A, Mateos Munoz B, Martinez Gonzalez J, Ortega JD, de la Fuente Briongos E, Redondo PD, Cano CC, Alvarez LP, Pieter CEC, Remizova MO, Gonzalez Silva I, Ferrer Blanco A, Claros LS, Tejedor-Tejada J, Jimenez Jurado A, Mazzola VKC, Cabal IB, Leoz D, Rivas E, Calvo A, Herreros-de-Tejada A, de Frutos Rosa D, Gomez FV, Gutierrez Landaluce P, Colomet RM, Diez PF, Blanco Garcia L, Castano Fernandez O, Ruiz Zorrilla Lopez R, Lorenzo MEM, Lopez Fernandez E, Sierra Morales M, Garcia Centeno P, Maestro Prada I, Vazquez-Sequeiros E, Albillos Martinez A; Mucosal Resection and Third-Space Endoscopy SEED Working Group. Temporary interruption versus maintenance of anticoagulation in polypectomy of colorectal lesions: study protocol for a multicentre randomised non-inferiority clinical trial POLYPHEM. BMJ Open. 2026 Mar 30;16(3):e111695. doi: 10.1136/bmjopen-2025-111695. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
The intervention consists of managing anticoagulation in two different ways during colorectal polypectomy: Comparison of Temporary Interruption of Anticoagulation (Standard of Care) vs. Continuation of Anticoagulation (Interventional Arm)
Not provided
Not provided
Not provided
Unscheduled hospitalization for the treatment of unstable angina occurring within 24 hours from symptom onset. Hospitalization is defined as admission to an inpatient unit or an emergency department visit resulting in a stay of at least 24 hours. Data collected will include event date, hospital stay duration, and ICU stay duration. |
| 1 month |
| Deep Vein Thrombosis | Any deep vein thrombosis diagnosed in the upper body (internal jugular, subclavian, axillary/brachial) or lower extremities (iliac, femoral/popliteal, gastrocnemius, peroneal, posterior tibial), or in the inferior vena cava or deep splanchnic veins, as confirmed by ultrasound or contrast imaging techniques including computed tomography (CT), angiography, or magnetic resonance imaging (MRI). Data collected will include event date, hospital stay duration, and ICU stay duration. | 1 month |
| Pulmonary Embolism | Any pulmonary embolism diagnosed by computed tomography (CT), ventilation-perfusion (V/Q) scan, invasive pulmonary angiography, echocardiography (thrombus visualized in the main pulmonary artery), or confirmed by autopsy. Data collected will include event date, hospital stay duration, and ICU stay duration. | 1 month |
| Stroke, Including Transient Ischemic Attack | Stroke is defined as an acute episode of focal or global neurological dysfunction caused by a cerebral, spinal, or retinal vascular injury as a result of hemorrhage or infarction. Transient ischemic attack (TIA) is defined as a temporary (< 24 hours) episode of focal neurological dysfunction caused by cerebral, spinal, or retinal ischemia without acute infarction. Data collected will include event date, hospital stay duration, and ICU stay duration. | 1 month |
| Peripheral Arterial Embolism or Thrombosis | Any embolism or arterial thrombosis diagnosed by computed tomography (CT), ultrasound, or magnetic resonance imaging (MRI) involving the splanchnic circulation, upper or lower extremities, or renal arteries. Data collected will include event date, type, hospital stay duration, and ICU stay duration. | 1 month |
| Clinically non-significant intraprocedural bleeding | Bleeding that persists for more than 1 minute, requires endoscopic treatment, and does not meet the criteria for clinically significant intraprocedural bleeding. | 1 month |
| Death | It will be recorded as a nominal categorical variable: - No/death If death is selected: Cause/unknown cause. It will be also recorded the date of death | 1 month |
| Torrelavega |
| Cantabria |
| 39300 |
| Spain |
| Servicio de Gastroenterología y Hepatología. Hospital Universitario Río Hortega. | Valladolid | Castille and León | 47012 | Spain |
| Servicio de Digestología, Hospital del Mar. Instituto Hospital del Mar de Investigaciones Médicas. | Barcelona | Catalonia | 08003 | Spain |
| Hospital Clinic de Barcelona | Barcelona | Catalonia | 08036 | Spain |
| Servicio de Gastroenterología. Hospital Universitario Príncipe de Asturias. Madrid. | Alcalá de Henares | Madrid | 28805 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid | Spain |
| Servicio de Gastroenterología y Hepatología. Unidad de Endoscopias. Hospital Universitario Puerta De Hierro. | Majadahonda | Madrid | 28222 | Spain |
| Servicio de Gastroenterología y Hepatología. Hospital Universitario San Agustín. | Avilés | Principality of Asturias | 33401 | Spain |
| Servicio de Aparato Digestivo. Hospital Universitario de Cabueñes | Oviedo | Principality of Asturias | 33011 | Spain |