Towards a Tailored Approach for Patients With Acute Diverticulitis and Abscess Formation. A Multicenter Cohort Analysis

Sepsis Clinical Trial

— DivAbsc2023  

Official title:

Towards a Tailored Approach for Patients With Acute Diverticulitis and Abscess Formation. A Multicenter Cohort Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109506
• Other study ID #: DivAbsc2023_1
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 30, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult (=18 years of age) patients

2. Patients diagnosed with acute diverticulitis with radiological findings of contained perforation (modified Hinchey classification Ib and IIa/b).

3. Patients who are initially managed conservatively according to contemporary guidelines.

Exclusion Criteria:

1. Patients with perforated diverticulitis with peritonitis (Hinchey III or IV stages).

2. Patients with clinically assessed generalized peritonitis.

3. Patients diagnosed with colonic cancer mimicking acute diverticulitis with abscess.

4. Requirement for urgent or emergent surgery decided immediately following hospital admission.

Related Conditions & MeSH terms

• Abscess
• Acute Diverticulitis
• Diverticulitis
• Diverticulitis of Sigmoid
• Diverticulitis, Colonic
• Diverticulum
• Sepsis

Intervention

Procedure:
• Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess
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.

Locations

Country	Name	City	State
Italy	University of Cagliari Hospital	Cagliari

Sponsors (2)

Lead Sponsor	Collaborator
University of Cagliari	Azienda Ospedaliero Universitaria di Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 days after the beginning of conservative treatment.
Secondary	Number of patients with recurrence of acute diverticulitis.	Recurrence of symptomatic acute diverticulitis requiring a new hospital admission.	90 days after initial successful conservative treatment and hospital discharge.