Prospective Observational Analysis of Circulating Endocan Levels in Patients Presenting With Acute Diverticulitis

NCT07027007 | Not Yet Recruiting

• 1 other identifier: DIVENDO STUDY
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diverticulitis

Keywords

endocan; acute diverticolitis; diverticulitis classification

Outcome Measures

Primary Outcomes (1)

• Endocan serum level at admission

  To evaluate the correlation between blood concentration of endocan and severity of diverticulitis

  The serum of the patients enrolled inthe study will be collected within two hours from emergency room registation and tested for ENDOCAN

Secondary Outcomes (2)

• Predictive value of endocan in determining which patients need emergency surgery

  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

  From discharge after definitive tretament till 12 months follow-up

Study Arms (1)

patients with acute diverticulitis

Patients admitted to the emergency department with acute diverticulitis classified according to WSES statements.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by acute diverticulitis in the emergency department

You may qualify if:

• Patients who have signed informed consent
• Patients who are affected by acute diverticulitis after clinical evaluation and imaging (i.e. u.s. or CeCT)

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (1)

Emergency Department IRCCS San Raffaele

Milan, milano, 20132, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum samples

MeSH Terms

Conditions

Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 18, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)