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

Primary Purpose

Diverticulitis, Colonic, Colonic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Colonoscopy
Fecal immunochemical and occult blood test
Fecal calprotectin test
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diverticulitis, Colonic focused on measuring Diverticulitis, Advanced colonic neoplasm, Colonoscopy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Parc de Salut Mar. Hospital del Mar.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Complicated diverticulitis

Uncomplicated diverticulitis

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

CT predictive value for ACN detection
Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis.
Clinical symptoms predictive value for ANC detection
Assessment of diagnostic prediction of clinical symptoms to detect ANC in acute diverticulitis.
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.
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.
FIT predictive value for ANC detection
Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis.
Fecal calprotectin test predictive value for ANC detection
Assessment of diagnostic prediction of fecal calprotectin test to detect ANC in acute diverticulitis.

Full Information

First Posted
June 4, 2018
Last Updated
September 27, 2022
Sponsor
Parc de Salut Mar
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1. Study Identification

Unique Protocol Identification Number
NCT03557216
Brief Title
Acute Diverticulitis and Advanced Colonic Neoplasia. When to Perform Colonoscopy (ADACOLON Study)
Acronym
ADACOLON
Official Title
Clinical Trial for the Determination of Advanced Colonic Neoplasia Prevalence and the Need for Colonoscopy in Complicated and Uncomplicated Acute Diverticulitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
August 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parc de Salut Mar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis, Colonic, Colonic Neoplasms
Keywords
Diverticulitis, Advanced colonic neoplasm, Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Diagnostic clinical trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complicated diverticulitis
Arm Type
Experimental
Arm Description
Patients with complicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed.
Arm Title
Uncomplicated diverticulitis
Arm Type
Experimental
Arm Description
Patients with uncomplicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Colonoscopy
Intervention Description
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
Intervention Name(s)
Fecal immunochemical and occult blood test
Other Intervention Name(s)
FIT
Intervention Description
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
Intervention Name(s)
Fecal calprotectin test
Intervention Description
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 Outcome Measure Information:
Title
Presence of ACN
Description
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.
Time Frame
At the moment of colonoscopy.
Secondary Outcome Measure Information:
Title
CT predictive value for ACN detection
Description
Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis.
Time Frame
At the moment of colonoscopy.
Title
Clinical symptoms predictive value for ANC detection
Description
Assessment of diagnostic prediction of clinical symptoms to detect ANC in acute diverticulitis.
Time Frame
At the moment of colonoscopy.
Title
Colonoscopy quality
Description
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.
Time Frame
At the moment of colonoscopy.
Title
Colonoscopy security
Description
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.
Time Frame
30 days post-colonoscopy.
Title
FIT predictive value for ANC detection
Description
Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis.
Time Frame
At the moment of colonoscopy.
Title
Fecal calprotectin test predictive value for ANC detection
Description
Assessment of diagnostic prediction of fecal calprotectin test to detect ANC in acute diverticulitis.
Time Frame
At the moment of colonoscopy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustín Seoane Urgorri, MD
Organizational Affiliation
Parc de Salut Mar. Hospital del Mar.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc de Salut Mar. Hospital del Mar.
City
Barcelona
ZIP/Postal Code
08003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available
IPD Sharing Time Frame
Data will be available within 6 months of study completion
IPD Sharing Access Criteria
Data access will be shared with the principal investigators of all the hospitals that participate in the study
Citations:
PubMed Identifier
26453777
Citation
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.
Results Reference
background
PubMed Identifier
24434085
Citation
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.
Results Reference
background
PubMed Identifier
18523784
Citation
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.
Results Reference
background

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

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