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

Not Applicable

Completed

• Conditions: Colonic Neoplasms; Diverticulitis, Colonic

• Registration Number: NCT03557216
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-13
• Study First Posted: 2018-06-14
• Study Start: 2018-06-15
• Status Verified: 2022-04
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-23
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Presence of ACN	At the moment of colonoscopy.	For our study, ANC is all colonic lesions that are advanced adenoma or colorectal cancer. Advanced adenoma is defined as that adenoma with size\> 10mm, villous component in\> 25% and / or high-grade dysplasia or all serrated lesions\> 10mm with or without dysplasia. Colonoscopy is the gold standard for ANC detection.

Secondary Outcome Measures

Name	Time	Method
Clinical symptoms predictive value for ANC detection	At the moment of colonoscopy.	Assessment of diagnostic prediction of clinical symptoms to detect ANC in acute diverticulitis.
Fecal calprotectin test predictive value for ANC detection	At the moment of colonoscopy.	Assessment of diagnostic prediction of fecal calprotectin test to detect ANC in acute diverticulitis.
CT predictive value for ACN detection	At the moment of colonoscopy.	Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis.
Colonoscopy quality	At the moment of colonoscopy.	A quality colonoscopy will be considered as a complete colonoscopy, with an adequate preparation according to the Boston scale (score greater than or equal to 2 in all segments) and with resection of all polyps \<20mm detected.
FIT predictive value for ANC detection	At the moment of colonoscopy.	Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis.
Colonoscopy security	30 days post-colonoscopy.	Assessment of complications arising from colonoscopy. Mayor complication of colonoscopy is defined as the presence of perforation, hemorrhage, postpolypectomy syndrome, thromboembolic accident, acute myocardial infarction and / or death, and minor complication of colonoscopy for the rest of the events.

Trial Locations

Locations (1)

Parc de Salut Mar. Hospital del Mar.; 🇪🇸 Barcelona, Spain