Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04407793
Other study ID # DICRO-2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 25, 2020
Est. completion date May 25, 2023

Study information

Verified date June 2020
Source Hospital Universitari de Bellvitge
Contact Marta C Climent
Phone +34655321809
Email martacliment@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Locations

Country Name City State
Spain Hospital Universitari Bellvitge Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Sebastiano Biondo

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence of acute diverticulitis To detect which patients with acute diverticulitis recur 2 years
Primary 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
Primary Faecal calprotectine To correlate faecal calprotectine with acute diverticulitis recurrence 2 years
Primary 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 HRQL (Health Related Quality of Life) QUESTIONNAIRES 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)
2 years
See also
  Status Clinical Trial Phase
Completed NCT02785549 - Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics Phase 4
Completed NCT03008707 - Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)
Recruiting NCT02817854 - PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study N/A
Completed NCT03279588 - Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis
Recruiting NCT06023004 - The Diverticulitis Study
Not yet recruiting NCT06388538 - The COLD2B Multicenter, Two-arm Prospective Cohort Study
Recruiting NCT06109506 - Towards a Tailored Approach for Patients With Acute Diverticulitis and Abscess Formation. A Multicenter Cohort Analysis
Recruiting NCT03643718 - Web-based International Register of Emergency Surgery and Trauma
Recruiting NCT04596280 - Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study
Recruiting NCT06344078 - Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR).
Recruiting NCT06265649 - Comparison of NOM for ACLD Between Medical and Surgical Ward
Completed NCT04663490 - Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis
Recruiting NCT05162560 - Incidence and Outcome of Acute Diverticulitis in Finland
Enrolling by invitation NCT05085353 - Fetal Outcomes Among Pregnant Emergency General Surgery Patients
Completed NCT01840904 - Subjective Sleep and Fatigue During and After Acute Diverticulitis N/A
Completed NCT01840852 - Sleep and Cytokines During Acute Diverticulitis N/A
Completed NCT01609751 - Prevention of Diverticulitis by Taking a Daily Probiotic N/A
Completed NCT01840917 - Heart Rate Variability During Acute Diverticulitis N/A
Not yet recruiting NCT01825967 - Acute Diverticulitis and C-Reactive Protein as a Prognostic Marker N/A
Completed NCT01840878 - Validation of Actigraph Measured Sleep During Acute Diverticulitis N/A