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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03557216
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diverticulitis, Colonic Colonic Neoplasms Diagnostic Test: Colonoscopy Diagnostic Test: Fecal immunochemical and occult blood test Diagnostic Test: Fecal calprotectin test Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 527 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Diagnostic clinical trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Trial for the Determination of Advanced Colonic Neoplasia Prevalence and the Need for Colonoscopy in Complicated and Uncomplicated Acute Diverticulitis
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.
Other Name: FIT

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.
Experimental: 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.
 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.
Other Name: FIT

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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557216


Contacts
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Contact: Agustín Seoane Urgorri, MD 932483000 ext 3057 92847@parcdesalutmar.cat
Contact: Diana Zaffalón Espinal, MD 932483000 ext 3057 dianatze@gmail.com

Locations
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Spain
Parc de Salut Mar. Hospital del Mar. Recruiting
Barcelona, Spain, 08003
Contact: Agustín Seoane Urgorri, MD    93248300 ext 3057    92847@parcdesalutmar.cat   
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: Agustín Seoane Urgorri, MD Parc de Salut Mar. Hospital del Mar.
More Information
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Publications:

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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03557216    
Other Study ID Numbers: ADACOLON
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Data access will be shared with the principal investigators of all the hospitals that participate in the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
Diverticulitis
Advanced colonic neoplasm
Colonoscopy
Additional relevant MeSH terms:
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Colonic Neoplasms
Diverticulitis
Diverticulitis, Colonic
Neoplasms
Diverticular Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Intestinal Diseases
Diverticulosis, Colonic