Diverticulitis, ColonicADACOLONNCT03557216
Acute Diverticulitis and Advanced Colonic Neoplasia. When to Perform Colonoscopy (ADACOLON Study)
A study testing Colonoscopy, Fecal immunochemical and occult blood test and Fecal calprotectin test in people with Diverticulitis, Colonic and Colonic Neoplasms, run by Parc de Salut Mar at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diverticulitis, Colonic, Colonic Neoplasms
- What is being tested?
- Colonoscopy, Fecal immunochemical and occult blood test and Fecal calprotectin test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2018to 23 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial for the Determination of Advanced Colonic Neoplasia Prevalence and the Need for Colonoscopy in Complicated and Uncomplicated Acute Diverticulitis
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.
Read the 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
- Being tested
- Colonoscopy, Fecal immunochemical and occult blood test, Fecal calprotectin test
- Keywords
- Diverticulitis, Advanced colonic neoplasm, Colonoscopy
- Medical subject headings
- Diverticulitis, Colonic, Colonic Neoplasms, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDiagnostic 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 testDiagnostic test
Also called FIT
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 testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Complicated diverticulitis | Experimental | Patients with complicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed. Receives: Diagnostic Test: Colonoscopy; Diagnostic Test: Fecal immunochemical and occult blood test; Diagnostic Test: Fecal calprotectin test |
| Uncomplicated diverticulitis | Experimental | Patients with uncomplicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed. Receives: Diagnostic Test: Colonoscopy; Diagnostic Test: Fecal immunochemical and occult blood test; Diagnostic Test: Fecal calprotectin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the moment of colonoscopy.
Secondary outcomes (6)
CT predictive value for ACN detection
Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis.
Measured: At the moment of colonoscopy.
Clinical symptoms predictive value for ANC detection
Assessment of diagnostic prediction of clinical symptoms to detect ANC in acute diverticulitis.
Measured: At the moment of colonoscopy.
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.
Measured: At the moment of colonoscopy.
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.
Measured: 30 days post-colonoscopy.
FIT predictive value for ANC detection
Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis.
Measured: At the moment of colonoscopy.
Fecal calprotectin test predictive value for ANC detection
Assessment of diagnostic prediction of fecal calprotectin test to detect ANC in acute diverticulitis.
Measured: At the moment of colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start15 Jun 2018
- Primary completion30 Jun 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diverticulitis, ColonicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Diagnostic clinical trial
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agustín Seoane Urgorri, MD, Principal investigator, Parc de Salut Mar. Hospital del Mar.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557216
- Sponsor's protocol ID
- ADACOLON
- Acronym
- ADACOLON
- Status last verified
- Apr 2022
- First submitted
- 4 Jun 2018
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Publications
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.
PubMed 26453777Daniels 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.
PubMed 24434085Lameris 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.
PubMed 18523784
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Determination of Advanced Colonic Neoplasia Prevalence and the Need for Colonoscopy in Complicated and Uncomplicated Acute Diverticulitis
- ClinicalTrials.gov ID
- NCT03557216
- Acronym / sponsor ID
- ADACOLON / ADACOLON
- Conditions
- Diverticulitis, Colonic, Colonic Neoplasms
- Keywords
- Diverticulitis, Advanced colonic neoplasm, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Diagnostic clinical trial
| Arm | Type | Receives |
|---|---|---|
| Complicated diverticulitis | Experimental | Diagnostic Test: Colonoscopy, Diagnostic Test: Fecal immunochemical and occult blood test, Diagnostic Test: Fecal calprotectin testPatients with complicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed. |
| Uncomplicated diverticulitis | Experimental | Diagnostic Test: Colonoscopy, Diagnostic Test: Fecal immunochemical and occult blood test, Diagnostic Test: Fecal calprotectin testPatients with uncomplicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyAnal 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 | Complicated diverticulitis, Uncomplicated diverticulitis |
| Fecal immunochemical and occult blood testAlso: FITA 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 | Complicated diverticulitis, Uncomplicated diverticulitis |
| Fecal calprotectin testCalprotectin 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. | Diagnostic test | Complicated diverticulitis, Uncomplicated diverticulitis |
Primary outcome
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.
6 secondary outcomes
CT predictive value for ACN detection
Time frame: At the moment of colonoscopy.
Clinical symptoms predictive value for ANC detection
Time frame: At the moment of colonoscopy.
Colonoscopy quality
Time frame: At the moment of colonoscopy.
Colonoscopy security
Time frame: 30 days post-colonoscopy.
FIT predictive value for ANC detection
Time frame: At the moment of colonoscopy.
Fecal calprotectin test predictive value for ANC detection
Time frame: At the moment of colonoscopy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Background: PubMed 26453777Stollman 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.
- Background: PubMed 24434085Daniels 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.
- Background: PubMed 18523784Lameris 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agustín Seoane Urgorri, MD principal investigator
Parc de Salut Mar. Hospital del Mar.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy, Fecal immunochemical and occult blood test and Fecal calprotectin test in people with Diverticulitis, Colonic and Colonic Neoplasms, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of ACN (time frame: At the moment of colonoscopy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03557216, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.