NCT03557216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2022

Completed
Last Updated

September 28, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

June 4, 2018

Last Update Submit

September 27, 2022

Conditions

Diverticulitis, ColonicColonic Neoplasms

Keywords

DiverticulitisAdvanced colonic neoplasmColonoscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the moment of colonoscopy.

Secondary Outcomes (6)

  • CT predictive value for ACN detection

    At the moment of colonoscopy.

  • Clinical symptoms predictive value for ANC detection

    At the moment of colonoscopy.

  • Colonoscopy quality

    At the moment of colonoscopy.

  • Colonoscopy security

    30 days post-colonoscopy.

  • FIT predictive value for ANC detection

    At the moment of colonoscopy.

  • +1 more secondary outcomes

Study Arms (2)

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.

Diagnostic Test: ColonoscopyDiagnostic Test: Fecal immunochemical and occult blood testDiagnostic 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.

Diagnostic Test: ColonoscopyDiagnostic Test: Fecal immunochemical and occult blood testDiagnostic Test: Fecal calprotectin test

Interventions

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

Complicated diverticulitisUncomplicated diverticulitis
Fecal immunochemical and occult blood testDIAGNOSTIC_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.

Also known as: FIT
Complicated diverticulitisUncomplicated diverticulitis
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.

Complicated diverticulitisUncomplicated diverticulitis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc de Salut Mar. Hospital del Mar.

Barcelona, 08003, Spain

Location

Related Publications (3)

  • 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.

    PMID: 26453777BACKGROUND

  • 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.

    PMID: 24434085BACKGROUND

  • 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.

    PMID: 18523784BACKGROUND

MeSH Terms

Conditions

Diverticulitis, ColonicColonic NeoplasmsDiverticulitis

Interventions

ColonoscopyOccult Blood

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesDiverticulosis, ColonicColonic DiseasesIntestinal DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresClinical Laboratory TechniquesInvestigative Techniques

Study Officials

  • Agustín Seoane Urgorri, MD

    Parc de Salut Mar. Hospital del Mar.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Diagnostic clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 14, 2018

Study Start

June 15, 2018

Primary Completion

June 30, 2022

Study Completion

August 23, 2022

Last Updated

September 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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

Locations

ES(1)