Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study

Acute Diverticulitis Clinical Trial

Official title:

Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596280
• Other study ID #: DT - 01- 2020
• Status: Recruiting
• Start date: January 2010
• Est. completion date: December 2020

Study information

• Verified date: October 2020
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Diverticulitis
• Diverticulitis

Intervention

Procedure:
• Colonic Resection
Resection of the colonic tract which has been interested by the acute diverticulitis

Locations

Country	Name	City	State
Italy	AOUPisana	Pisa	Tuscany

Sponsors (4)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana	Azienda sanitaria universitaria Giuliano Isontina (ASU GI), Hospital San Jacopo, San Filippo Neri General Hospital

Country where clinical trial is conducted

Italy, 

Outcome

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