Education to prevent infections after spleen removal
Evaluation of an Educational Intervention on Knowledge and Awareness of Infectious Risk in Splenectomized Patients and on Their Satisfaction With Vaccination Management in an Intra-hospital Outpatient Setting.
See if a targeted educational program for adults who had their spleen removed improves vaccination uptake, awareness of infection risk, and continuity of care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 2 sites (Rome, Lazio and 1 other locations) |
| Trial ID | NCT07354893 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational registry enrolling adults who undergo splenectomy at Fondazione Policlinico Universitario A. Gemelli IRCCS and who consent to an in-hospital vaccination consultation. Clinical, sociodemographic, and vaccination-related data are recorded in a dedicated database, and patient-reported outcomes are collected with structured questionnaires administered before and after a standardized educational intervention. Patients who complete the vaccination pathway are followed longitudinally by outpatient visits or structured telephone interviews to monitor vaccine uptake and schedule completion. Data are pseudonymized and managed according to Good Clinical Practice and applicable data protection regulations.
Who should consider this trial
Good fit: Adults (≥18 years) who undergo splenectomy at the Gemelli hospital and request or receive an in-hospital vaccination consultation and provide informed consent are ideal candidates.
Not a fit: Patients splenectomized at other hospitals, minors, those who decline consent, or individuals already fully vaccinated and adherent to prevention measures are unlikely to gain additional benefit from this program.
Why it matters
Potential benefit: If successful, the program could increase timely vaccination and preventive behaviors and thereby reduce the risk of overwhelming post-splenectomy infection.
How similar studies have performed: Post-splenectomy vaccination is proven to reduce OPSI risk and prior interventions in other settings have improved vaccine uptake, but single-center educational registries of this exact design are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years old) * Patients splenectomized at FPG for whom a vaccination consultation is requested during hospitalization * Patients who provide signed informed consent to participate in the study and for the processing of personal data for research purposes Exclusion Criteria: * Minor patients * Lack of signed informed consent for participation in the study and for the processing of personal data for research purposes * Patients splenectomized at other healthcare facilities
Where this trial is running
Rome, Lazio and 1 other locations
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Lazio, Italy (Recruiting)
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Laurenti Patrizia, Professor — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Laurenti Patrizia, Professor
- Email: patrizia.laurenti@policlinicogemelli.it
- Phone: 063015.9333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.