NCT04596280

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

10.9 years

First QC Date

October 15, 2020

Last Update Submit

October 28, 2020

Conditions

Acute Diverticulitis

Outcome Measures

Primary Outcomes (1)

  • Need for procedural intervention (operation or percutaneous drainage)

    30 day

Secondary Outcomes (4)

  • ICU requirement

    30 day

  • Overall morbidity

    30 day

  • Length of stay

    30 day

  • in-hospital morbidity

    30 day

Study Arms (3)

Hinchey Classification

Procedure: Colonic Resection

AAST classification

Procedure: Colonic Resection

WSES classfication

Procedure: Colonic Resection

Interventions

Colonic ResectionPROCEDURE

Resection of the colonic tract which has been interested by the acute diverticulitis

AAST classificationHinchey ClassificationWSES classfication

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute Colonic Diverticulitis

You may qualify if:

  • acute colonic diverticulitis

You may not qualify if:

  • Other severe conditions of end-life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUPisana

Pisa, Tuscany, 56126, Italy

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.; M.D., Researcher, Principal investigator

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

January 1, 2010

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

IT(1)