Acute Diverticulitis and Advanced Colonic Neoplasia. When to Perform Colonoscopy (ADACOLON Study)

Parc de Salut Mar

Status: Completed

Conditions: Colonic Neoplasms; Diverticulitis, Colonic

Treatments: Diagnostic Test: Fecal immunochemical and occult blood test; Diagnostic Test: Colonoscopy; Diagnostic Test: Fecal calprotectin test

Study type: Interventional

Funder types: Other

Identifiers

NCT03557216

ADACOLON

Details and patient eligibility

About

This study evaluate the prevalence of advanced colonic neoplasia (ACN) in acute diverticulitis. A sub-analysis of complicated and uncomplicated acute diverticulitis will be made in order to determinate whether there are differences of advanced colonic neoplasia (ANC) prevalence in both groups and to assess if a colonoscopy is necessary.

Full description

This is a prospective study that eliminates biases in the selection, design and variability of retrospective studies to reliably assess the global prevalence of advanced colon neoplasia (ACN) and the difference in prevalence among populations with complicated and uncomplicated acute diverticulitis diagnosed by computed tomography. Another objective is to assess the diagnostic prediction of computed tomography to detect ACN in acute diverticulitis. It also aims to assess the safety and quality of colonoscopy in a patient recently diagnosed with acute diverticulitis. Finally, it aims to study whether other diagnostic tools such as the presence of clinical risk symptoms or the performance of fecal biological tests could help in narrowing the indication of colonoscopy in this clinical scenario.

Enrollment: 313 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients consecutively diagnosed with acute diverticulitis in the participating hospitals during the study inclusion period will be included. For this purpose, a multidetector computerized tomography confirming the diagnosis of acute diverticulitis must be performed on all patients with initial clinical suspicion.

Exclusion criteria

1. Patient refusal to participate in the study.
2. Impossibility of obtaining informed consent by the patient or guardian.
3. Age <18 years and> 85 years
4. Impossibility of performing a diagnostic CT of AD.
5. Intercurrent medical or surgical process with prolonged recovery in time that prevents a colonoscopy before 6 months after the resolution of the episode of acute diverticulitis.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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313 participants in 2 patient groups

Complicated diverticulitis

Experimental group

Description:

Patients with complicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed.

Treatment:

Diagnostic Test: Colonoscopy

Diagnostic Test: Fecal calprotectin test

Diagnostic Test: Fecal immunochemical and occult blood test

Uncomplicated diverticulitis

Experimental group

Description:

Patients with uncomplicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed.

Treatment:

Diagnostic Test: Colonoscopy

Diagnostic Test: Fecal calprotectin test

Diagnostic Test: Fecal immunochemical and occult blood test