NCT03557216

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diverticulitis, Colonic
• Colonic Neoplasms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Colonoscopy	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
DIAGNOSTIC_TEST	Fecal immunochemical and occult blood test	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.
DIAGNOSTIC_TEST	Fecal calprotectin test	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.

Timeline

• Start date: 2018-06-15
• Primary completion: 2022-06-30
• Completion: 2022-08-23
• First posted: 2018-06-14
• Last updated: 2022-09-28

Locations

1 site across 1 country: Spain