Acute DiverticulitisDivAbsc2023NCT06109506
Towards a Tailored Approach for Patients With Acute Diverticulitis and Abscess Formation. A Multicenter Cohort Analysis
An observational study of Acute Diverticulitis and Diverticular Diseases, run by University of Cagliari at 1 site in Italy.
Trial summary
It is estimated that approximately 15% to 20% of the subjects with sigmoid diverticulosis will develop acute diverticulitis, with diverticular abscess as the most common complication of sigmoid diverticulitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Diverticulitis, Diverticular Diseases, Diverticulitis of Sigmoid
- What is being tested?
- Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2023to 30 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient cohort consists of adult (≥18 years of age) patients with a diagnosis of acute diverticulitis complicated by localized intra-abdominal abscess formation with pericolic or pelvic localization and/or localized pericolic extraluminal air, corresponding to the modified Hinchey classification Ib and IIa/b. These patients should be managed conservatively according to contemporary guidelines, but still have a high probability for failure of conservative treatment.
Who may be able to join
- Adult (≥18 years of age) patients
- Patients diagnosed with acute diverticulitis with radiological findings of contained perforation (modified Hinchey classification Ib and IIa/b).
- Patients who are initially managed conservatively according to contemporary guidelines.
Who cannot join
- Patients with perforated diverticulitis with peritonitis (Hinchey III or IV stages).
- Patients with clinically assessed generalized peritonitis.
- Patients diagnosed with colonic cancer mimicking acute diverticulitis with abscess.
- Requirement for urgent or emergent surgery decided immediately following hospital admission.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Cagliari Hospital
Cagliari
Mauro Podda, MD, FACS, 07051096571, mauropodda@ymail.com
mauro.podda@unica.it
About this study
It is estimated that approximately 15% to 20% of the subjects with sigmoid diverticulosis will develop acute diverticulitis, with diverticular abscess as the most common complication of sigmoid diverticulitis.
While cases with free perforations and diffuse peritonitis require emergency surgery, in cases with contained perforation and abscess formation, the approach is initially conservative. Due to its relative rarity, the treatment of diverticular abscess is not based on high-quality scientific evidence. Abscess size of 4-6 cm is generally accepted as reasonable cutoff determining the choice of treatment between antibiotic therapy and antibiotic therapy plus percutaneous drainage of the abscess.
Read more
A subgroup of patients will fail the conservative approach and require a surgical rescue strategy. However, the real incidence for conservative treatment failure after non-operative management of acute diverticulitis with abscess remain poorly understood, the knowledge of which could improve decision-making processes, treatment strategies, patient counseling, and even modify the planned treatment strategy in patients deemed at highest risk.
The early recognition of patients who show clinical signs of ongoing and worsening intra-abdominal sepsis due to perforation is important to ensure the success of this strategy. In the light of these, knowledge of risk predictors for failure is of utmost importance.
Owing the contrasting evidence summary, we set up a multicenter retrospective cohort study that merges the cases from twelve high-volume centers for emergency surgery in Italy to assess the short-term outcomes of initial non-surgical treatment strategies for AD with abscess formation (Hinchey Ib and II) in a large number of patients, and identify risk factors associated with adverse outcomes, to help facilitate appropriate patient selection and assess the optimal treatment strategy for this peculiar subgroup of patients.
The purpose of this study is to describe the incidence and risk factors for conservative treatment (antibiotics alone or antibiotics plus percutaneous drainage) failure after non-operative management of acute diverticulitis with abscess using a large multicenter patient series.
The present study is designed as a multicenter retrospective observational study conducted at twelve secondary and tertiary Italian teaching surgical centers on CT-diagnosed hemodynamically stable patients (≥18 years) with perforated acute diverticulitis with abscess (with or without extraluminal air) initially treated non-surgically.
The rate of failure of non-operative treatment for complicated acute diverticulitis patients with abscess formation and the risk factors of failure of the non-surgical treatment will be assessed.
Failure of the conservative treatment is defined as lack of clinical improvement in the general conditions of the patient during index hospital admission, requiring urgent surgery to treat intra-abdominal sepsis.
- Conditions
- Acute Diverticulitis, Diverticular Diseases, Diverticulitis of Sigmoid, Acute Diverticular Perforation, Diverticulitis, Colonic, Sepsis
- Being tested
- Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess
- Keywords
- Acute diverticulitis, Diverticular abscess, Conservative treatment
- Medical subject headings
- Diverticular Diseases, Diverticulitis, Colonic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscessProcedure or surgery
Patients with acute diverticulitis and abscess formation are commonly treated with a conservative approach that includes endovenous antibiotics and, for abscesses > 4-5 cm, percutaneous image-guided drainage.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diverticular abscess classified as Hinchey 2b (Subgroup) | Not described Receives: Procedure: Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess | |
| Patients with diverticular abscess >5 cm (Subgroup) | Not described Receives: Procedure: Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with failure of the conservative treatment.
Failure of the conservative treatment is defined as the need for emergency surgical therapy performed during the index hospitalization due to clinical deterioration in spite of initial diverticular abscess treatment with antibiotics +/- percutaneous drainage.
Measured: 15 days after the beginning of conservative treatment.
Secondary outcomes (1)
Number of patients with recurrence of acute diverticulitis.
Recurrence of symptomatic acute diverticulitis requiring a new hospital admission.
Measured: 90 days after initial successful conservative treatment and hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Jun 2023
- Primary completion1 Nov 2023
- Study completion30 Nov 2023 (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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria di Cagliari
- Responsible party
- Principal investigator, Mauro Podda, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109506
- Sponsor's protocol ID
- DivAbsc2023_1
- Acronym
- DivAbsc2023
- Status last verified
- Dec 2023
- First submitted
- 23 Oct 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Podda M, Ceresoli M, Di Martino M, Ortenzi M, Pellino G, Pata F, Ielpo B, Murzi V, Balla A, Lepiane P, Tamini N, De Carlo G, Davolio A, Di Saverio S, Cardinali L, Botteri E, Vettoretto N, Gelera PP, De Simone B, Grasso A, Clementi M, Meloni D, Poillucci G, Favi F, Rizzo R, Montori G, Procida G, Recchia I, Agresta F, Virdis F, Cioffi SPB, Pellegrini M, Sartelli M, Coccolini F, Catena F, Pisanu A. Towards a tailored approach for patients with acute diverticulitis and abscess formation. The DivAbsc2023 multicentre case-control study. Surg Endosc. 2024 Jun;38(6):3180-3194. doi: 10.1007/s00464-024-10793-z. Epub 2024 Apr 17.
PubMed 38632117
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Tailored Approach for Patients With Acute Diverticulitis and Abscess Formation. A Multicenter Cohort Analysis
- ClinicalTrials.gov ID
- NCT06109506
- Acronym / sponsor ID
- DivAbsc2023 / DivAbsc2023_1
- Conditions
- Acute Diverticulitis, Diverticular Diseases, Diverticulitis of Sigmoid, Acute Diverticular Perforation, Diverticulitis, Colonic, Sepsis
- Keywords
- Acute diverticulitis, Diverticular abscess, Conservative treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria di Cagliari
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 31 Oct 2023 (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.
It is estimated that approximately 15% to 20% of the subjects with sigmoid diverticulosis will develop acute diverticulitis, with diverticular abscess as the most common complication of sigmoid diverticulitis.
While cases with free perforations and diffuse peritonitis require emergency surgery, in cases with contained perforation and abscess formation, the approach is initially conservative. Due to its relative rarity, the treatment of diverticular abscess is not based on high-quality scientific evidence. Abscess size of 4-6 cm is generally accepted as reasonable cutoff determining the choice of treatment between antibiotic therapy and antibiotic therapy plus percutaneous drainage of the abscess.
A subgroup of patients will fail the conservative approach and require a surgical rescue strategy. However, the real incidence for conservative treatment failure after non-operative management of acute diverticulitis with abscess remain poorly understood, the knowledge of which could improve decision-making processes, treatment strategies, patient counseling, and even modify the planned treatment strategy in patients deemed at highest risk.
The early recognition of patients who show clinical signs of ongoing and worsening intra-abdominal sepsis due to perforation is important to ensure the success of this strategy. In the light of these, knowledge of risk predictors for failure is of utmost importance.
Owing the contrasting evidence summary, we set up a multicenter retrospective cohort study that merges the cases from twelve high-volume centers for emergency surgery in Italy to assess the short-term outcomes of initial non-surgical treatment strategies for AD with abscess formation (Hinchey Ib and II) in a large number of patients, and identify risk factors associated with adverse outcomes, to help facilitate appropriate patient selection and assess the optimal treatment strategy for this peculiar subgroup of patients.
The purpose of this study is to describe the incidence and risk factors for conservative treatment (antibiotics alone or antibiotics plus percutaneous drainage) failure after non-operative management of acute diverticulitis with abscess using a large multicenter patient series.
The present study is designed as a multicenter retrospective observational study conducted at twelve secondary and tertiary Italian teaching surgical centers on CT-diagnosed hemodynamically stable patients (≥18 years) with perforated acute diverticulitis with abscess (with or without extraluminal air) initially treated non-surgically.
The rate of failure of non-operative treatment for complicated acute diverticulitis patients with abscess formation and the risk factors of failure of the non-surgical treatment will be assessed.
Failure of the conservative treatment is defined as lack of clinical improvement in the general conditions of the patient during index hospital admission, requiring urgent surgery to treat intra-abdominal sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with diverticular abscess classified as Hinchey 2b (Subgroup) | – | Procedure: Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess |
| Patients with diverticular abscess >5 cm (Subgroup) | – | Procedure: Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient cohort consists of adult (≥18 years of age) patients with a diagnosis of acute diverticulitis complicated by localized intra-abdominal abscess formation with pericolic or pelvic localization and/or localized pericolic extraluminal air, corresponding to the modified Hinchey classification Ib and IIa/b. These patients should be managed conservatively according to contemporary guidelines, but still have a high probability for failure of conservative treatment.
Key inclusion criteria (3 listed)
- Adult (≥18 years of age) patients
- Patients diagnosed with acute diverticulitis with radiological findings of contained perforation (modified Hinchey classification Ib and IIa/b).
- Patients who are initially managed conservatively according to contemporary guidelines.
Key exclusion criteria (4 listed)
- Patients with perforated diverticulitis with peritonitis (Hinchey III or IV stages).
- Patients with clinically assessed generalized peritonitis.
- Patients diagnosed with colonic cancer mimicking acute diverticulitis with abscess.
- Requirement for urgent or emergent surgery decided immediately following hospital admission.
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 |
|---|---|---|
| Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscessPatients with acute diverticulitis and abscess formation are commonly treated with a conservative approach that includes endovenous antibiotics and, for abscesses > 4-5 cm, percutaneous image-guided drainage. | Procedure or surgery | Patients with diverticular abscess >5 cm (Subgroup), Patients with diverticular abscess classified as Hinchey 2b (Subgroup) |
Primary outcome
Number of patients with failure of the conservative treatment.
Time frame: 15 days after the beginning of conservative treatment.
Failure of the conservative treatment is defined as the need for emergency surgical therapy performed during the index hospitalization due to clinical deterioration in spite of initial diverticular abscess treatment with antibiotics +/- percutaneous drainage.
1 secondary outcome
Number of patients with recurrence of acute diverticulitis.
Time frame: 90 days after initial successful conservative treatment and hospital discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 38632117Podda M, Ceresoli M, Di Martino M, Ortenzi M, Pellino G, Pata F, Ielpo B, Murzi V, Balla A, Lepiane P, Tamini N, De Carlo G, Davolio A, Di Saverio S, Cardinali L, Botteri E, Vettoretto N, Gelera PP, De Simone B, Grasso A, Clementi M, Meloni D, Poillucci G, Favi F, Rizzo R, Montori G, Procida G, Recchia I, Agresta F, Virdis F, Cioffi SPB, Pellegrini M, Sartelli M, Coccolini F, Catena F, Pisanu A. Towards a tailored approach for patients with acute diverticulitis and abscess formation. The DivAbsc2023 multicentre case-control study. Surg Endosc. 2024 Jun;38(6):3180-3194. doi: 10.1007/s00464-024-10793-z. Epub 2024 Apr 17.
- Individual participant dataSharing planned: Yes
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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 and Diverticular Diseases, run by University of Cagliari 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 3 inclusion and 4 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 5 Dec 2023. 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?
Number of patients with failure of the conservative treatment. (time frame: 15 days after the beginning of conservative treatment.). 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 NCT06109506, 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 5 Dec 2023.