Clinical trial NCT03557216: Acute Diverticulitis and Advanced Colonic Neoplasia. When to Perform Colonoscopy (ADACOLON Study)
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
Overall status: COMPLETED
Phase: NA
Conditions: Diverticulitis, Colonic
Colonic Neoplasms
Keywords: Diverticulitis
Advanced colonic neoplasm
Colonoscopy
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Diagnostic clinical trial
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Presence of ACN
timeFrame: At the moment of colonoscopy.
Secondary outcomes:
measure: CT predictive value for ACN detection
timeFrame: At the moment of colonoscopy.
measure: Clinical symptoms predictive value for ANC detection
timeFrame: At the moment of colonoscopy.
measure: Colonoscopy quality
timeFrame: At the moment of colonoscopy.
measure: Colonoscopy security
timeFrame: 30 days post-colonoscopy.
measure: FIT predictive value for ANC detection
timeFrame: At the moment of colonoscopy.
measure: Fecal calprotectin test predictive value for ANC detection
timeFrame: At the moment of colonoscopy.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc de Salut Mar. Hospital del Mar.
Study officials:
affiliation: Parc de Salut Mar. Hospital del Mar.
name: Agustín Seoane Urgorri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.