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

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ClinicalTrials.gov Identifier: NCT05833698
Recruitment Status : Not yet recruiting
First Posted : April 27, 2023
Last Update Posted : April 27, 2023
Sponsor:
Information provided by (Responsible Party):
Alba Correa Bonito, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Description
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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
Acute Uncomplicated Diverticulitis Diagnostic Test: Elevation of NLR

Study Design
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Study Type : Observational
Estimated 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.
Estimated Study Start Date : June 15, 2023
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with failure of conservative treatment Diagnostic Test: Elevation of NLR
Blood test
Other Name: Elevation of PLR
Patients without failure of conservative treatment Diagnostic Test: Elevation of NLR
Blood test
Other Name: Elevation of PLR


Outcome Measures
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Primary Outcome Measures :
  1. Failure of conservative treatment with antibiotics [ Time Frame: 15th june 2023-31st december 2024 ]
  2. Failure of conservative treatment without antibiotics [ Time Frame: 15th june 2023-31st december 2024 ]

Secondary Outcome Measures :
  1. Evaluate the accuracy of PLR and NLR as predictors of failure [ Time Frame: 15th june 2023-31st december 2024 ]
  2. Analysis of trends in managemente of acute uncomplicated diverticulitis [ Time Frame: 15th june 2023-31st december 2024 ]

Eligibility Criteria
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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:   Non-Probability Sample
Study Population
All patients over 18 years, diagnosed of acute uncomplicated diverticulitis
Criteria

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
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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): NCT05833698


Locations
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Spain
Hospital Universitario de La Princesa
Madrid, Spain, 28060
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
More Information
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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: April 27, 2023    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases