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

NCT ID: NCT03557216

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 313 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2022-08-23

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.

Conditions

Diverticulitis, Colonic; Colonic Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Complicated diverticulitis

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

Group Type: EXPERIMENTAL

Colonoscopy

Intervention Type: 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

Intervention Type: 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.

Fecal calprotectin test

Intervention Type: 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.

Uncomplicated diverticulitis

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

Group Type: EXPERIMENTAL

Colonoscopy

Intervention Type: 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

Intervention Type: 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.

Fecal calprotectin test

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

FIT

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agustín Seoane Urgorri, MD

Role: PRINCIPAL_INVESTIGATOR

Parc de Salut Mar. Hospital del Mar.

Locations

Parc de Salut Mar. Hospital del Mar.

Barcelona, , Spain

Countries

Spain

References

Stollman N, Smalley W, Hirano I; AGA Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on the Management of Acute Diverticulitis. Gastroenterology. 2015 Dec;149(7):1944-9. doi: 10.1053/j.gastro.2015.10.003. Epub 2015 Oct 8. No abstract available.

Reference Type: BACKGROUND

PMID: 26453777 (View on PubMed)

Daniels L, Unlu C, de Wijkerslooth TR, Dekker E, Boermeester MA. Routine colonoscopy after left-sided acute uncomplicated diverticulitis: a systematic review. Gastrointest Endosc. 2014 Mar;79(3):378-89; quiz 498-498.e5. doi: 10.1016/j.gie.2013.11.013. Epub 2014 Jan 14. No abstract available.

Reference Type: BACKGROUND

PMID: 24434085 (View on PubMed)

Lameris W, van Randen A, Bipat S, Bossuyt PM, Boermeester MA, Stoker J. Graded compression ultrasonography and computed tomography in acute colonic diverticulitis: meta-analysis of test accuracy. Eur Radiol. 2008 Nov;18(11):2498-511. doi: 10.1007/s00330-008-1018-6. Epub 2008 Jun 4.

Reference Type: BACKGROUND

PMID: 18523784 (View on PubMed)

Other Identifiers

ADACOLON

Identifier Type: -

Identifier Source: org_study_id