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

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ClinicalTrials.gov Identifier: NCT04407793
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Sebastiano Biondo, Hospital Universitari de Bellvitge

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.


Condition or disease
Acute Diverticulitis

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prospective and Multicentre Study on Clinical-biological Factors Predictive of Chronic Colon DIverticulitis
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : May 25, 2021
Estimated Study Completion Date : May 25, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Diverticulitis Group
Patients with acute diverticulitis episode
Diverticulosis group
Patients diagnosed with diverticulosis without any acute diverticulitis episode
Non-diverticulosis
Patients without diverticulosis



Primary Outcome Measures :
  1. Recurrence of acute diverticulitis [ Time Frame: 2 years ]
    To detect which patients with acute diverticulitis recur

  2. Systemic inflammatory markers [ Time Frame: 2 years ]

    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.


  3. Faecal calprotectine [ Time Frame: 2 years ]
    To correlate faecal calprotectine with acute diverticulitis recurrence

  4. Local inflammatory markers [ Time Frame: 2 years ]

    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.


Secondary Outcome Measures :
  1. HRQL (Health Related Quality of Life) QUESTIONNAIRES [ Time Frame: 2 years ]

    To correlate clinical symptoms with inflammatory markers.

    Questionnaires used:

    • SF-12 Health Survey, in order to measure Mental and Physical Health. There are 8 areas with a minimum value of 0 (the worst health state) and a maximum of 100 (best health state)
    • GIQLI (Gastrointestinal Quality of Life questionnaire). Minimum value of 0 (the worst health state) and a maximum of 100 (best health state)


Biospecimen Retention:   Samples Without DNA
Faecal samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407793


Contacts
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Contact: Marta C Climent +34655321809 martacliment@gmail.com

Locations
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Spain
Hospital Universitari Bellvitge Recruiting
Barcelona, Spain, 08034
Contact: Marta C Climent    655321809    martacliment@gmail.com   
Sponsors and Collaborators
Sebastiano Biondo
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Responsible Party: Sebastiano Biondo, Sebastiano Biondo. Clinical Professor. Head of Surgery Department, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT04407793    
Other Study ID Numbers: DICRO-2020
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sebastiano Biondo, Hospital Universitari de Bellvitge:
Acute diverticulitis
Chronic diverticulitis
Recurrence
Diverticulitis treatment
Additional relevant MeSH terms:
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Diverticulitis
Diverticulitis, Colonic
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases