NCT05833698

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,160

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

April 16, 2023

Last Update Submit

April 26, 2023

Conditions

Acute Uncomplicated Diverticulitis

Outcome Measures

Primary Outcomes (2)

  • Failure of conservative treatment with antibiotics

    15th june 2023-31st december 2024

  • Failure of conservative treatment without antibiotics

    15th june 2023-31st december 2024

Secondary Outcomes (2)

  • Evaluate the accuracy of PLR and NLR as predictors of failure

    15th june 2023-31st december 2024

  • Analysis of trends in managemente of acute uncomplicated diverticulitis

    15th june 2023-31st december 2024

Study Arms (2)

Patients with failure of conservative treatment

Diagnostic Test: Elevation of NLR

Patients without failure of conservative treatment

Diagnostic Test: Elevation of NLR

Interventions

Elevation of NLRDIAGNOSTIC_TEST

Blood test

Also known as: Elevation of PLR
Patients with failure of conservative treatmentPatients without failure of conservative treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients over 18 years, diagnosed of acute uncomplicated diverticulitis

You may qualify if:

  • Patients older than 18, diagnosed of acute uncomplicated diverticulitis.
  • Diagnosis made by CT or ultrasound

You may not qualify if:

  • Patients younger than 18.
  • Patients diagnosed of acute complicated diverticulitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, 28060, Spain

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 16, 2023

First Posted

April 27, 2023

Study Start

June 15, 2023

Primary Completion

March 31, 2024

Study Completion

December 31, 2024

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations

ES(1)