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Completed

NCT Number: NCT03557216

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

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.

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Key information

Conditions

Diverticulitis, Colonic Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Diverticular Diseases Diverticulitis Diverticulosis, Colonic Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parc de Salut Mar. Hospital del Mar.

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colonoscopy

Diagnostic Test

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

Fecal immunochemical and occult blood test

Diagnostic 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.

Other names: FIT

Fecal Calprotectin Test

Diagnostic 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.

Primary outcomes

  1. Presence of ACN

    Time frame: 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 outcomes

  1. CT predictive value for ACN detection

    Time frame: At the moment of colonoscopy.

    Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis.

  2. Clinical symptoms predictive value for ANC detection

    Time frame: At the moment of colonoscopy.

    Assessment of diagnostic prediction of clinical symptoms to detect ANC in acute diverticulitis.

  3. Colonoscopy quality

    Time frame: 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.

  4. Colonoscopy security

    Time frame: 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.

  5. FIT predictive value for ANC detection

    Time frame: At the moment of colonoscopy.

    Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis.

  6. Fecal calprotectin test predictive value for ANC detection

    Time frame: At the moment of colonoscopy.

    Assessment of diagnostic prediction of fecal calprotectin test to detect ANC in acute diverticulitis.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Acronym: ADACOLON

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2018
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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