Open AccessThe Diverticular Disease Registry (DDR Trial) by the Advanced International Mini-Invasive Surgery Academy Clinical Research Network: Protocol for a Multicenter, Prospective Observational Study
Author(s) -
Matteo Origi,
Pietro Achilli,
Giacomo Calini,
Andrea Costanzi,
M. Monteleone,
Isacco Montroni,
Dario Maggioni,
Eugenio Cocozza,
Stefano Megna,
Mauro Totis,
Nicolò Tamini,
Antonio Ziccarelli,
G Filippone,
Giovanni Ferrari,
Jacopo Crippa,
Antonino Spinelli,
Giulio Mari
Publication year - 2021
Publication title -
international journal of surgery protocols
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.291
H-Index - 4
ISSN - 2468-3574
DOI - 10.29337/ijsp.157
Subject(s) - diverticular disease , medicine , diverticulitis , observational study , clinical trial , diverticulosis , randomized controlled trial , prospective cohort study , cohort , surgery , quality of life (healthcare) , cohort study , general surgery , nursing
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 (NCT04907383). Data collection will be recorded on Research Electronic Data Capture (REDCap) starting on June 1 st , 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.