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

NCT06109506 | Unknown

• 1 other identifier: DivAbsc2023_1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diverticulitis; Diverticular Diseases; Diverticulitis of Sigmoid; Acute Diverticular Perforation; Diverticulitis, Colonic; Sepsis

Keywords

Acute diverticulitis; Diverticular abscess; Conservative treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of patients with recurrence of acute diverticulitis.

  90 days after initial successful conservative treatment and hospital discharge.

Study Arms (2)

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

Interventions

Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess PROCEDURE

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); Patients with diverticular abscess classified as Hinchey 2b (Subgroup)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cagliari: lead
• Azienda Ospedaliero Universitaria di Cagliari: collaborator

Study Sites (1)

University of Cagliari Hospital

Cagliari, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 38632117 DERIVED

MeSH Terms

Conditions

Diverticular Diseases; Diverticulitis, Colonic; Sepsis

Interventions

Conservative Treatment; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Diverticulitis; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer of Surgery

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 31, 2023
• Study Start: June 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 30, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

IT (1)