The Diverticular Disease Registry (DDR Trial) by the Advanced International Mini-Invasive Surgery Academy Clinical Research Network: Protocol for a Multicenter, Prospective Observational Study
| Autor: | Stefano Megna, Matteo Origi, Mauro Totis, Giovanni Ferrari, Andrea Costanzi, Gaetano Filippone, Giacomo Calini, Dario Maggioni, Jacopo Crippa, Eugenio Cocozza, Antonino Spinelli, Giulio Mari, Michela Monteleone, Antonio Ziccarelli, Pietro Achilli, Isacco Montroni, Nicolò Tamini |
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| Přispěvatelé: | Matteo Origi, Pietro Achilli, Giacomo Calini, Andrea Costanzi, Michela Monteleone, Isacco Montroni, Dario Maggioni, Eugenio Cocozza, Stefano Megna, Mauro Toti, Nicolo’ Tamini, Antonio Ziccarelli, Gaetano Filippone, Giovanni Ferrari, Jacopo Crippa, Antonino Spinelli, Giulio M. Mari |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
diverticular disease diverticulosis Quality of life Protocol Medicine clinical protocols Prospective cohort study diverticuliti medicine.diagnostic_test business.industry diverticulosi General surgery Interventional radiology Diverticulitis medicine.disease Diverticulosis body regions diverticulitis multicenter study Diverticular disease Surgery Observational study business clinical protocol Cohort study prospective study |
| Zdroj: | International Journal of Surgery Protocols |
| Popis: | Diverticular disease is an increasingly common issue, with a variety of clinical presentations and treatment options. However, very few prospective cohort studies explore outcomes between the different presentations and treatments. The Diverticular Disease Registry (DDR Trial) is a multicenter, prospective, observational cohort study on behalf of the Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network. The DDR Trial aims to investigate the short-term postoperative and long-term quality of life outcomes in patients undergoing surgery or medical treatments for diverticular disease. DDR Trial is open to participation by all tertiary-care hospitals. DDR Trial has been registered at ClinicalTrials.gov (NCT 04907383). Data collection will be recorded on Research Electronic Data Capture (REDCap) starting on June 1st, 2021 and will end after 5 years of recruitment. All adult patients with imaging-proven colonic diverticular disease (i.e., symptomatic colonic diverticulosis including diverticular bleeding, diverticulitis, and Symptomatic Uncomplicated Diverticular Disease) will be included. The primary outcome of DDR Trial is quality of life assessment at 12-month according to the Gastrointestinal Quality of Life Index (GIQLI). The secondary outcome is 30-day postoperative outcomes according to the Clavien-Dindo classification. DDR Trial will significantly advance in identifying the optimal care for patients with diverticular disease by exploring outcomes of different presentations and treatments. Highlights Diverticular disease (i.e., diverticulitis, bleeding) has different treatments. This is a clinical protocol for the Diverticular Disease Registry (DDR Trial). DDR Trial is a multicenter, prospective, observational cohort study open to participation. DDR Trial will study short-term postoperative and long-term quality of life outcomes. Medical treatments, interventional radiology and surgery will be explored. |
| Databáze: | OpenAIRE |
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