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

Recruiting

• Conditions: Diverticular Diseases; Diverticulitis of Sigmoid; Acute Diverticular Perforation; Sepsis; Diverticulitis, Colonic; Acute Diverticulitis
• Interventions: Procedure: Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess

• Registration Number: NCT06109506
• Lead Sponsor: University of Cagliari

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-10-31
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-02
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with diverticular abscess classified as Hinchey 2b (Subgroup)	Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess	-
Patients with diverticular abscess >5 cm (Subgroup)	Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess	-

Primary Outcome Measures

Name	Time	Method
Number of patients with failure of the conservative treatment.	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients with recurrence of acute diverticulitis.	90 days after initial successful conservative treatment and hospital discharge.	Recurrence of symptomatic acute diverticulitis requiring a new hospital admission.

Trial Locations

Locations (1)

University of Cagliari Hospital; 🇮🇹 Cagliari, Italy