Not yet recruiting NCT07027007
Prospective Observational Analysis of Circulating Endocan Levels in Patients Presenting With Acute Diverticulitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diverticulitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Quantify the level of endocan in blood samples collected from patients with acute diverticulitis in the emergency department. Determine if endocan levels are correlated with the severity of diverticulitis according to the WSES classification. Assess whether patients requiring emergency surgical intervention have higher endocan values compared to others.
Primary outcome measures
- Endocan serum level at admission [Time frame: The serum of the patients enrolled inthe study will be collected within two hours from emergency room registation and tested for ENDOCAN]
Secondary outcome measures (2)
- Predictive value of endocan in determining which patients need emergency surgery [Time frame: Patients will undergo diverticulitis evaluations (per WSES criteria) within 3 hours of Emergency room admission and study enrollment]
- Prognostic value of endocan in determining the risk of recurrent diveritculitis [Time frame: From discharge after definitive tretament till 12 months follow-up]
Eligibility criteria
Inclusion criteria
- Patients who have signed informed consent
- Patients who are affected by acute diverticulitis after clinical evaluation and imaging (i.e. u.s. or CeCT)
Exclusion criteria
- Immunosuppressed patients
- Patients suffering chronic inflammatory diseases
- Patients with concomitant malignancy, cardiac, renal and haepatic failure
- History of major vascular surgery (aneurysmectomy)
- Pregnant women
- Patients participating in other studies that may interfere with the outcome of the intervention.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Emergency Department IRCCS San Raffaele — Milan
Identifiers
NCT: NCT07027007 · DIVENDO STUDY