Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study

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

Study Overview

• Status: Unknown
• Conditions: Acute Diverticulitis
• Intervention / Treatment: Procedure: Colonic Resection

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Italy
  • Tuscany
    • Pisa, Tuscany, Italy, 56126
      • Recruiting
      • AOUPisana
      • Contact: Dario Tartaglia, PhD; MD; Phone Number: 3334491229; Email: dario.tartaglia@unipi.it
      • Sub-Investigator: Federico Coccolini, MD
      • Sub-Investigator: Massimo Chiarugi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute Colonic Diverticulitis

Description

Inclusion Criteria:

• acute colonic diverticulitis

Exclusion Criteria:

• Other severe conditions of end-life

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hinchey Classification	Procedure: Colonic Resection; Resection of the colonic tract which has been interested by the acute diverticulitis
AAST classification	Procedure: Colonic Resection; Resection of the colonic tract which has been interested by the acute diverticulitis
WSES classfication	Procedure: Colonic Resection; Resection of the colonic tract which has been interested by the acute diverticulitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Need for procedural intervention (operation or percutaneous drainage)	30 day

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU requirement	30 day
Overall morbidity	30 day
Length of stay	30 day
in-hospital morbidity	30 day

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Universitaria Pisana
• Collaborators: San Filippo Neri General Hospital; Hospital San Jacopo; Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis
• Other Study ID Numbers: DT - 01- 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No