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
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|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|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|
Patients with acute diverticulitis episode
Patients diagnosed with diverticulosis without any acute diverticulitis episode
Patients without diverticulosis
- Recurrence of acute diverticulitis [ Time Frame: 2 years ]To detect which patients with acute diverticulitis recur
- 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.
- Faecal calprotectine [ Time Frame: 2 years ]To correlate faecal calprotectine with acute diverticulitis recurrence
- 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.
- HRQL (Health Related Quality of Life) QUESTIONNAIRES [ Time Frame: 2 years ]
To correlate clinical symptoms with inflammatory markers.
- 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
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
|Contact: Marta C Climentfirstname.lastname@example.org|
|Hospital Universitari Bellvitge||Recruiting|
|Barcelona, Spain, 08034|
|Contact: Marta C Climent 655321809 email@example.com|