Clincosm LogoSign in Get a demo

Acute Uncomplicated Diverticulitis and Conservative Treatment: Accuracy of Inflammatory Indexes for Failure Prediction: Observational Prospective Cohort Study. (AUDRIP Trial)

Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05833698
Collaborator
(none)
2,160
Enrollment
1
Location
18.6
Anticipated Duration (Months)
116.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observational multicenter study that will analyse the accuracy of inflammatory indexes as neutrophil-lymphocyte ratio and platelet-lymphocyte ratio, to predict the failure of conservative treatment of patients diagnosed of acute uncomplicated diverticulitis.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Elevation of NLR

Study Design

Study Type:
Observational
Anticipated Enrollment :
2160 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Acute Uncomplicated Diverticulitis and Conservative Treatment: Accuracy of Inflammatory Indexes for Failure Prediction: Observational Prospective Cohort Study.
Anticipated Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients with failure of conservative treatment

Diagnostic Test: Elevation of NLR
Blood test
Other Names:
  • Elevation of PLR

    		•
    Patients without failure of conservative treatment

    Diagnostic Test: Elevation of NLR
    Blood test
    Other Names:
  • Elevation of PLR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Failure of conservative treatment with antibiotics [15th june 2023-31st december 2024]

    2. Failure of conservative treatment without antibiotics [15th june 2023-31st december 2024]

    Secondary Outcome Measures

    1. Evaluate the accuracy of PLR and NLR as predictors of failure [15th june 2023-31st december 2024]

    2. Analysis of trends in managemente of acute uncomplicated diverticulitis [15th june 2023-31st december 2024]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients older than 18, diagnosed of acute uncomplicated diverticulitis.

    • Diagnosis made by CT or ultrasound

    Exclusion Criteria:

    • Patients younger than 18.

    • Patients diagnosed of acute complicated diverticulitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario de La Princesa Madrid Spain 28060

    Sponsors and Collaborators

    • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alba Correa Bonito, MD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
    ClinicalTrials.gov Identifier:
    NCT05833698
    Other Study ID Numbers:
    • 5072
    First Posted:
    Apr 27, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diverticulitis

    Study Results

    No Results Posted as of Apr 27, 2023