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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

Tracking Information
First Submitted Date April 16, 2023
First Posted Date April 27, 2023
Last Update Posted Date April 27, 2023
Estimated Study Start Date June 15, 2023
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2023)
  • Failure of conservative treatment with antibiotics [ Time Frame: 15th june 2023-31st december 2024 ]
  • Failure of conservative treatment without antibiotics [ Time Frame: 15th june 2023-31st december 2024 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 26, 2023)
  • Evaluate the accuracy of PLR and NLR as predictors of failure [ Time Frame: 15th june 2023-31st december 2024 ]
  • Analysis of trends in managemente of acute uncomplicated diverticulitis [ Time Frame: 15th june 2023-31st december 2024 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Uncomplicated Diverticulitis and Conservative Treatment: Accuracy of Inflammatory Indexes for Failure Prediction: Observational Prospective Cohort Study. (AUDRIP Trial)
Official Title Acute Uncomplicated Diverticulitis and Conservative Treatment: Accuracy of Inflammatory Indexes for Failure Prediction: Observational Prospective Cohort Study.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients over 18 years, diagnosed of acute uncomplicated diverticulitis
Condition Acute Uncomplicated Diverticulitis
Intervention Diagnostic Test: Elevation of NLR
Blood test
Other Name: Elevation of PLR
Study Groups/Cohorts
  • Patients with failure of conservative treatment
    Intervention: Diagnostic Test: Elevation of NLR
  • Patients without failure of conservative treatment
    Intervention: Diagnostic Test: Elevation of NLR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 26, 2023)		 2160
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT05833698
Other Study ID Numbers 5072
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Alba Correa Bonito, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Original Responsible Party Same as current
Current Study Sponsor Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Verification Date April 2023