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

Study Overview
=================
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.

Official Title
-----------------
Clinical Trial for the Determination of Advanced Colonic Neoplasia Prevalence and the Need for Colonoscopy in Complicated and Uncomplicated Acute Diverticulitis

Conditions
-----------------
Diverticulitis, Colonic, Colonic Neoplasms

Intervention / Treatment
-----------------
* Diagnostic Test: Colonoscopy
* Diagnostic Test: Fecal immunochemical and occult blood test
* Diagnostic Test: Fecal calprotectin test


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Patient refusal to participate in the study. Impossibility of obtaining informed consent by the patient or guardian. Age <18 years and> 85 years Impossibility of performing a diagnostic CT of AD. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Diagnostic clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complicated diverticulitis<br>Patients with complicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed. | Diagnostic Test: Colonoscopy<br>* Anal introduction of a long, flexible, tubular instrument about 1/2-inch in diameter that transmits an image of the lining of the colon so the doctor can examine it for any abnormalities<br>Diagnostic Test: Fecal immunochemical and occult blood test<br>* A test for fecal occult blood looks for blood in your feces. It can be a sign of a problem in the digestive system, such as a polyp or cancer in the colon.<br>* Other names: FIT;Diagnostic Test: Fecal calprotectin test<br>* Calprotectin is a protein released by neutrophils. When there is inflammation in the colon, neutrophils move to the area and release calprotectin, resulting in an increased level in the stool. This test measures the level of calprotectin in stool as a way to detect inflammation and lesions in the colon.<br>|
| Experimental: Uncomplicated diverticulitis<br>Patients with uncomplicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed. | Diagnostic Test: Colonoscopy<br>* Anal introduction of a long, flexible, tubular instrument about 1/2-inch in diameter that transmits an image of the lining of the colon so the doctor can examine it for any abnormalities<br>Diagnostic Test: Fecal immunochemical and occult blood test<br>* A test for fecal occult blood looks for blood in your feces. It can be a sign of a problem in the digestive system, such as a polyp or cancer in the colon.<br>* Other names: FIT;Diagnostic Test: Fecal calprotectin test<br>* Calprotectin is a protein released by neutrophils. When there is inflammation in the colon, neutrophils move to the area and release calprotectin, resulting in an increased level in the stool. This test measures the level of calprotectin in stool as a way to detect inflammation and lesions in the colon.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of ACN | 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. | At the moment of colonoscopy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT predictive value for ACN detection | Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis. | At the moment of colonoscopy. | 
| Clinical symptoms predictive value for ANC detection | Assessment of diagnostic prediction of clinical symptoms to detect ANC in acute diverticulitis. | At the moment of colonoscopy. | 
| Colonoscopy quality | 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. | At the moment of colonoscopy. | 
| Colonoscopy security | 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. | 30 days post-colonoscopy. | 
| FIT predictive value for ANC detection | Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis. | At the moment of colonoscopy. | 
| Fecal calprotectin test predictive value for ANC detection | Assessment of diagnostic prediction of fecal calprotectin test to detect ANC in acute diverticulitis. | At the moment of colonoscopy. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diverticulitis, Advanced colonic neoplasm, Colonoscopy