Prospective and Multicentre Study on Clinical-biological Factors Predictive of Chronic Colon DIverticulitis

NCT04407793 | Unknown DMC

• 1 other identifier: DICRO-2020
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

MAIN OBJECTIVE: Description of predicted markers of acute diverticulitis crisis, using bivariate and multivariate analyses. Analysis of acute diverticulitis predictor swings. SIDE OBJECTIVES: Descriptive analysis of HRQL in the different measurement periods to establish the evolution of the disease. Correlate HRQL values of systemic and local inflammatory markers in the diverticulitis group. Sub-analysis of patients with immunosuppression to evaluate disease virulence compared to a group of patients without immunosuppression. STUDY TYPE: Clinical, observational, prospective and multicenter study (8 hospitals) with three study groups: patients diagnosed with acute diverticulitis attending emergencies, diverticulosis patients and patients without diverticulums. INCLUSION CRITERIA: Age \> 18years and radiological diagnosis by abdominal CT acute diverticulitis. EXCLUSION CRITERIA: Rejection of the patient -severe diverticulitis requiring urgent surgery -an inability to understand HRQL questionnaire - IBD - pregnancy or breastfeeding - acute diverticulitis within the prior year of the study - Roma IV criteria fulfilment. VARIABLES: Main variables: local and systemic inflammatory markers- faecal calprotectin. Secondary variables: recurrence of acute diverticulitis -the persistence of symptoms - SF 12 and GIQLI questionnaires. STATISTICS: Sample size: alpha error 0.05; beta error 0.20; bilateral; proportion 0.9 in the control group; 500 subjects group diverticulitis, 200 group diverticulosis and not diverticulums.

Conditions

Acute Diverticulitis

Keywords

Acute diverticulitis; Chronic diverticulitis; Recurrence; Diverticulitis treatment

Outcome Measures

Primary Outcomes (4)

• Recurrence of acute diverticulitis

  To detect which patients with acute diverticulitis recur

  2 years

• Systemic inflammatory markers

  To correlate systemic inflammatory markers with acute diverticulitis recurrence. \* Systemic inflammatory markers include: A blood test with leukocyte count and formula, C-reactive protein, albumin, Neutrophil-Lymphocyte ratio calculation, Platelet-lymphocyte ratio calculation, lymphocyte-monocyte ratio calculatio, Modified Glasgow Prognostic score calculation.

  2 years

• Faecal calprotectine

  To correlate faecal calprotectine with acute diverticulitis recurrence

  2 years

• Local inflammatory markers

  To correlate local inflammatory markers with systemic inflammatory markers and recurrence. \*Local inflammatory markers come from colonic endoscopic samples taken in the colonoscopy at 2 months after the acute diverticulitis episode. 2 samples are taken: * Sample A: 1-5cm of diverticulum that has participated in diverticulitis episode (correlated with the CT) * Sample B: 30cm of the area that has suffered diverticulitis. Sampling for the study of local inflammatory markers includes IL-6, IL-10, tumour necrosis factor (TNF), macrophages, eosinophils and calculation of inflammation index of Ulcerative Colitis.

  2 years

Secondary Outcomes (1)

• HRQL (Health Related Quality of Life) QUESTIONNAIRES

  2 years

Study Arms (3)

Diverticulitis Group

Patients with acute diverticulitis episode

Diverticulosis group

Patients diagnosed with diverticulosis without any acute diverticulitis episode

Non-diverticulosis

Patients without diverticulosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

DIVERTICULITIS COHORT: Patients with current acute diverticulitis, diagnosed with abdominal CT and not requiring urgent surgery for this reason

You may qualify if:

• Age \> 18years
• Current episode of acute diverticulitis diagnosed with abdominal CT

You may not qualify if:

• Rejection of the patient
• Severe diverticulitis requiring urgent surgery
• Inability to understand HRQL questionnaires
• IBD background
• Pregnancy or lactation
• Acute diverticulitis episodes within the prior year to the start of the study
• Patients who meet Roma IV criteria for IBS

Sponsors & Collaborators

• Sebastiano Biondo: lead

Study Sites (1)

Hospital Universitari Bellvitge

Barcelona, 08034, Spain

RECRUITING

Related Publications (1)

• Climent M, Sobrino L, Guardiola J, Kreisler E, Biondo S; DICRO Trial Group. Prospective and multicenter study on clinical-biological factors predictive of chronic colon diverticulitis: DICRO Trial. Int J Colorectal Dis. 2025 May 7;40(1):111. doi: 10.1007/s00384-025-04902-0.

  PMID: 40335755 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faecal samples

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marta C Climent

CONTACT

+34655321809; martacliment@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sebastiano Biondo. Clinical Professor. Head of Surgery Department

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 29, 2020
• Study Start: May 25, 2020
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2023
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

ES (1)