Acute DiverticulitisNCT04596280
Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study
An observational study of Acute Diverticulitis, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Acute Diverticulitis
- What is being tested?
- Colonic Resection
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Colonic Diverticulitis
Who may be able to join
- acute colonic diverticulitis
Who cannot join
- Other severe conditions of end-life
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUPisana
Pisa, Tuscany, 56126
Dario Tartaglia, PhD; MD, 3334491229, dario.tartaglia@unipi.it
Federico Coccolini, MD
About this 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
- Conditions
- Acute Diverticulitis
- Being tested
- Colonic Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic ResectionProcedure or surgery
Resection of the colonic tract which has been interested by the acute diverticulitis
| Study group | Role | What they receive |
|---|---|---|
| Hinchey Classification | Not described Receives: Procedure: Colonic Resection | |
| AAST classification | Not described Receives: Procedure: Colonic Resection | |
| WSES classfication | Not described Receives: Procedure: Colonic Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for procedural intervention (operation or percutaneous drainage)
Measured: 30 day
Secondary outcomes (4)
ICU requirement
Measured: 30 day
Overall morbidity
Measured: 30 day
Length of stay
Measured: 30 day
in-hospital morbidity
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study startJan 2010
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Collaborators
- San Filippo Neri General Hospital, Hospital San Jacopo, Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
- Responsible party
- Principal investigator, Dario Tartaglia, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596280
- Sponsor's protocol ID
- DT - 01- 2020
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cremonini C, Biloslavo A, Robustelli V, Giannessi S, Rossi Del Monte S, Mastronardi M, Musetti S, Strambi S, Coccolini F, Chiarugi M, Tartaglia D. What are the differences between the three most used classifications for acute colonic diverticulitis? A comparative multicenter study. J Trauma Acute Care Surg. 2024 Feb 1;96(2):326-331. doi: 10.1097/TA.0000000000004133. Epub 2023 Sep 4.
PubMed 37661307
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study
- ClinicalTrials.gov ID
- NCT04596280
- Acronym / sponsor ID
- DT - 01- 2020
- Conditions
- Acute Diverticulitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Collaborators
- San Filippo Neri General Hospital, Hospital San Jacopo, Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hinchey Classification | – | Procedure: Colonic Resection |
| AAST classification | – | Procedure: Colonic Resection |
| WSES classfication | – | Procedure: Colonic Resection |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Colonic Diverticulitis
Key inclusion criteria (1 listed)
- acute colonic diverticulitis
Key exclusion criteria (1 listed)
- Other severe conditions of end-life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonic ResectionResection of the colonic tract which has been interested by the acute diverticulitis | Procedure or surgery | AAST classification, Hinchey Classification, WSES classfication |
Primary outcome
Need for procedural intervention (operation or percutaneous drainage)
Time frame: 30 day
4 secondary outcomes
ICU requirement
Time frame: 30 day
Overall morbidity
Time frame: 30 day
Length of stay
Time frame: 30 day
in-hospital morbidity
Time frame: 30 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Derived from this study: PubMed 37661307Cremonini C, Biloslavo A, Robustelli V, Giannessi S, Rossi Del Monte S, Mastronardi M, Musetti S, Strambi S, Coccolini F, Chiarugi M, Tartaglia D. What are the differences between the three most used classifications for acute colonic diverticulitis? A comparative multicenter study. J Trauma Acute Care Surg. 2024 Feb 1;96(2):326-331. doi: 10.1097/TA.0000000000004133. Epub 2023 Sep 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Diverticulitis, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for procedural intervention (operation or percutaneous drainage) (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.