Author, as appears in the article.: Ramírez-Maldonado E; Rodrigo-Rodrigo M; Lopez Gordo S; Sanchez A; Coronado Llanos D; Sanchez R; Vaz J; Fondevila C; Jorba-Martin R
Department: Medicina i Cirurgia
URV's Author/s: Jorba Martin, Rosa Maria / Ramírez Maldonado, Ruby Elena
Keywords: Pancreatic surgery Pancreatic disease Clinical trials
Abstract: INTRODUCTION: Acute pancreatitis (AP) is the third most common gastrointestinal disease resulting in hospital admission, with over 70% of AP admissions being mild cases. In the USA, it costs 2.5 billion dollars annually. The most common standard management of mild AP (MAP) still is hospital admission. Patients with MAP usually achieve complete recovery in less than a week and the severity predictor scales are reliable. The aim of this study will be to compare three different strategies for the management of MAP. METHODS/DESIGN: This is a randomised, controlled, three-arm multicentre trial. Patients with MAP will be randomly assigned to group A (outpatient), B (home care) or C (hospital admission). The primary endpoint of the trial will be the treatment failure rate of the outpatient/home care management for patients with MAP compared with that of hospitalised patients. The secondary endpoints will be pain relapse, diet intolerance, hospital readmission, hospital length of stay, need for intensive care unit admission, organ failure, complications, costs and patient satisfaction. The general feasibility, safety and quality checks required for high-quality evidence will be adhered to. ETHICS AND DISSEMINATION: The study (version 3.0, 10/2022) has been approved by the Scientific and Research Ethics Committee of the 'Institut d'Investigació Sanitaria Pere Virgili-IISPV' (093/2022). This study will provide evidence as to whether outpatient/home care is similar to usual management of AP. The conclusions of this study will be published in an open-access journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05360797).
Thematic Areas: Saúde coletiva Psicología Odontología Nutrição Medicine, general & internal Medicine (miscellaneous) Medicine (all) Medicina veterinaria Medicina iii Medicina ii Medicina i Interdisciplinar General medicine Farmacia Ensino Enfermagem Educação física Ciências biológicas iii Ciências biológicas ii Ciências biológicas i Ciências ambientais Ciência da computação Biotecnología
licence for use: https://creativecommons.org/licenses/by/3.0/es/
Author's mail: rubyelena.ramirez@urv.cat rosamaria.jorba@urv.cat
Author identifier: 0000-0003-3307-4340
Record's date: 2024-08-03
Papper version: info:eu-repo/semantics/publishedVersion
Link to the original source: https://bmjopen.bmj.com/content/13/6/e071265
Licence document URL: https://repositori.urv.cat/ca/proteccio-de-dades/
Papper original source: Bmj Open. 13 (6): e071265-
APA: Ramírez-Maldonado E; Rodrigo-Rodrigo M; Lopez Gordo S; Sanchez A; Coronado Llanos D; Sanchez R; Vaz J; Fondevila C; Jorba-Martin R (2023). Home care/outpatient versus hospital admission in mild acute pancreatitis: protocol of a multicentre, randomised controlled trial (PADI_2 trial). Bmj Open, 13(6), e071265-. DOI: 10.1136/bmjopen-2022-071265
Article's DOI: 10.1136/bmjopen-2022-071265
Entity: Universitat Rovira i Virgili
Journal publication year: 2023
Publication Type: Journal Publications