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

April 26, 2023 updated by: Alba Correa Bonito, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28060
        • Hospital Universitario de la Princesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients over 18 years, diagnosed of acute uncomplicated diverticulitis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Failure of conservative treatment with antibiotics
Time Frame: 15th june 2023-31st december 2024
15th june 2023-31st december 2024
Failure of conservative treatment without antibiotics
Time Frame: 15th june 2023-31st december 2024
15th june 2023-31st december 2024

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the accuracy of PLR and NLR as predictors of failure
Time Frame: 15th june 2023-31st december 2024
15th june 2023-31st december 2024
Analysis of trends in managemente of acute uncomplicated diverticulitis
Time Frame: 15th june 2023-31st december 2024
15th june 2023-31st december 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2023

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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