NCT03325829

Brief Summary

To determine the clinical characteristics and risk factors for the onset of diverticular disease and its complications in the Italian population.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Status
unknown

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

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

October 26, 2017

Last Update Submit

October 26, 2017

Conditions

Diverticulum, ColonDiverticulitis

Keywords

RegistryDiverticular DiseaseDiverticulitisUncomplicated Diverticular Disease

Outcome Measures

Primary Outcomes (1)

  • Risk factors of diverticulosis/ diverticular disease

    Evaluation of demographic and clinical characteristics, including comorbidities and co-treatment, able to characterize the subgroups of patients with diverticular disease

    Five years

Secondary Outcomes (1)

  • Risk of complications of diverticular disease and the factors of risk and protection against complications

    Five years

Other Outcomes (1)

  • Clinical aspects of diverticulosis/ diverticular disease

    Five years

Study Arms (1)

Patients with colonic diverticula

No interventional study

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with colonic diverticula

You may qualify if:

  • Acceptance to sign the Informed Consent form
  • Age \>18
  • Instrumental evidence (endoscopic or radiological) of diverticula in the colon.

You may not qualify if:

  • Refusal to sign the Informed Consent form
  • Inability to comply with the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Annibale B, Lahner E, Maconi G, Usai P, Marchi S, Bassotti G, Barbara G, Cuomo R. Clinical features of symptomatic uncomplicated diverticular disease: a multicenter Italian survey. Int J Colorectal Dis. 2012 Sep;27(9):1151-9. doi: 10.1007/s00384-012-1488-5. Epub 2012 May 10.

    PMID: 22573184BACKGROUND

  • Cuomo R, Barbara G, Andreozzi P, Bassotti G, Casetti T, Grassini M, Ierardi E, Maconi G, Marchi S, Sarnelli G, Savarino V, Usai P, Vozzella L, Annibale B. Symptom patterns can distinguish diverticular disease from irritable bowel syndrome. Eur J Clin Invest. 2013 Nov;43(11):1147-55. doi: 10.1111/eci.12152. Epub 2013 Sep 2.

    PMID: 23992370BACKGROUND

  • Annibale B, Maconi G, Lahner E, De Giorgi F, Cuomo R. Efficacy of Lactobacillus paracasei sub. paracasei F19 on abdominal symptoms in patients with symptomatic uncomplicated diverticular disease: a pilot study. Minerva Gastroenterol Dietol. 2011 Mar;57(1):13-22.

    PMID: 21372765BACKGROUND

  • Maconi G, Barbara G, Bosetti C, Cuomo R, Annibale B. Treatment of diverticular disease of the colon and prevention of acute diverticulitis: a systematic review. Dis Colon Rectum. 2011 Oct;54(10):1326-38. doi: 10.1097/DCR.0b013e318223cb2b.

    PMID: 21904150BACKGROUND

  • Zullo A, Hassan C, Maconi G, Manes G, Tammaro G, De Francesco V, Annibale B, Ficano L, Buri L, Gatto G, Lorenzetti R, Campo SM, Ierardi E, Pace F, Morini S. Cyclic antibiotic therapy for diverticular disease: a critical reappraisal. J Gastrointestin Liver Dis. 2010 Sep;19(3):295-302.

    PMID: 20922195BACKGROUND

  • Carabotti M, Marasco G, Sbarigia C, Cuomo R, Barbara G, Pace F, Sarnelli G, Annibale B; at behalf of REMAD group. Site and duration of abdominal pain discriminate symptomatic uncomplicated diverticular disease from previous diverticulitis patients. Intern Emerg Med. 2024 Aug;19(5):1235-1245. doi: 10.1007/s11739-024-03588-6. Epub 2024 Apr 27.

    PMID: 38671294DERIVED

  • Cremon C, Carabotti M, Cuomo R, Pace F, Andreozzi P, Barbaro MR, Annibale B, Barbara G. Italian nationwide survey of pharmacologic treatments in diverticular disease: Results from the REMAD registry. United European Gastroenterol J. 2019 Jul;7(6):815-824. doi: 10.1177/2050640619845990. Epub 2019 Apr 20.

    PMID: 31316786DERIVED

MeSH Terms

Conditions

Diverticulum, ColonDiverticulitisDiverticular Diseases

Condition Hierarchy (Ancestors)

DiverticulumGastroenteritisGastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Gastroenterology

Study Record Dates

First Submitted

October 26, 2017

First Posted

October 30, 2017

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

April 1, 2020

Last Updated

October 30, 2017

Record last verified: 2017-10