Acute Diverticulitis Clinical Trial
Official title:
Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study
NCT number | NCT04596280 |
Other study ID # | DT - 01- 2020 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | December 2020 |
Verified date | October 2020 |
Source | Azienda Ospedaliero, Universitaria Pisana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Even though Hinchey classification requires operative intervention, yet remains the established and most universally used scoring system for acute diverticulitis. Several other classifications have been described. The American Association for the Surgery of Trauma (AAST) developed a severity scale for surgical conditions, including diverticulitis. The same was done by the World Society of Emergency Surgery, that proposed a specific classification mainly based on the CT scan findings. This is a pilot study to compare the AAST and WSES classifications for acute colonic diverticulitis with the traditional Hinchey classification. We hypothesize that all the classifications are equivalent one each other in predicting outcomes
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 100 Years |
Eligibility | Inclusion Criteria: - acute colonic diverticulitis Exclusion Criteria: - Other severe conditions of end-life |
Country | Name | City | State |
---|---|---|---|
Italy | AOUPisana | Pisa | Tuscany |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero, Universitaria Pisana | Azienda sanitaria universitaria Giuliano Isontina (ASU GI), Hospital San Jacopo, San Filippo Neri General Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Need for procedural intervention (operation or percutaneous drainage) | 30 day | ||
Secondary | ICU requirement | 30 day | ||
Secondary | Overall morbidity | 30 day | ||
Secondary | Length of stay | 30 day | ||
Secondary | in-hospital morbidity | 30 day |
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