NCT06109506: DivAbsc2023

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

Status unknown Last updated 5 December 2023

What this trial tests

trial testing Conservative treatment with antibiotics and eventual percutaneous image-guided drainage of the abscess in Acute Diverticulitis in 400 participants. Status unknown.

Timeline

1 June 2023

Primary endpoint
1 November 2023

30 November 2023

Quick facts

Lead sponsor	University of Cagliari
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	400
Start date	1 June 2023
Primary completion	1 November 2023
Estimated completion	30 November 2023
Sites	1 location across Italy

Drugs / interventions tested

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

Conditions studied

• Acute Diverticulitis — all drugs for Acute Diverticulitis →
• Diverticular Diseases — all drugs for Diverticular Diseases →
• Diverticulitis of Sigmoid — all drugs for Diverticulitis of Sigmoid →
• Acute Diverticular Perforation — all drugs for Acute Diverticular Perforation →

Sponsor

University of Cagliari

Who can join

18 and older, any sex, with Acute Diverticulitis or Diverticular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Towards a tailored approach for patients with acute diverticulitis and abscess formation. The DivAbsc2023 multicentre case-control study.
   Podda M, Ceresoli M, Di Martino M, Ortenzi M, et al · · 2024 · cited 1× · PMID 38632117 · DOI 10.1007/s00464-024-10793-z