Towards a Tailored Approach for Patients With Acute Diverticulitis and Abscess Formation. A Multicenter Cohort Analysis (DivAbsc2023)

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 Overview

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

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Italy
  • Cagliari, Italy
    • Recruiting
    • University of Cagliari Hospital
    • Sub-Investigator: Federico Coccolini, MD
    • Sub-Investigator: Marco Clementi, MD
    • Sub-Investigator: Emanuele Botteri, MD
    • Contact: Mauro Podda, MD, FACS; Phone Number: 07051096571; Email: mauropodda@ymail.com
    • Contact: Email: mauro.podda@unica.it
    • Sub-Investigator: Marcello Di Martino, MD
    • Sub-Investigator: Gianluca Pellino, MD
    • Sub-Investigator: Francesco Pata, MD
    • Sub-Investigator: Benedetto Ielpo, MD
    • Sub-Investigator: Valentina Murzi, MD
    • Sub-Investigator: Andrea Balla, MD
    • Sub-Investigator: Pasquale Lepiane, MD
    • Sub-Investigator: Marco Ceresoli, MD
    • Sub-Investigator: Nicolo' Tamini, MD
    • Sub-Investigator: Giulia De Carlo, MD
    • Sub-Investigator: Alessia Davolio, MD
    • Sub-Investigator: Salomone Di Saverio, MD
    • Sub-Investigator: Luca Cardinali, MD
    • Sub-Investigator: Nereo Vettoretto, MD
    • Sub-Investigator: Pierpaolo Gelera, MD
    • Sub-Investigator: Belinda De Simone, MD
    • Sub-Investigator: Antonella Grasso, MD
    • Sub-Investigator: Danilo Meloni, MD
    • Sub-Investigator: Gaetano Poillucci, MD
    • Sub-Investigator: Francesco Favi, MD
    • Sub-Investigator: Roberta Rizzo, MD
    • Sub-Investigator: Giulia Montori, MD
    • Sub-Investigator: Giuseppe Procida, MD
    • Sub-Investigator: Irene Recchia, MD
    • Sub-Investigator: Ferdinando Agresta, MD
    • Sub-Investigator: Francesco Virdis, MD
    • Sub-Investigator: Stefano PB Cioffi, MD
    • Sub-Investigator: Martina Pellegrini, MD
    • Sub-Investigator: Monica Ortenzi, MD
    • Sub-Investigator: Massimo Sartelli, MD
    • Sub-Investigator: Fausto Catena, MD
    • Sub-Investigator: Adolfo Pisanu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 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.
Patients with diverticular abscess >5 cm (Subgroup)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Cagliari
• Collaborators: Azienda Ospedaliero Universitaria di Cagliari

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Conservative treatment; Acute diverticulitis; Diverticular abscess
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Inflammation; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Suppuration; Diverticulosis, Colonic; Abscess; Diverticulitis; Diverticulum; Diverticular Diseases; Diverticulitis, Colonic; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: DivAbsc2023_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No