Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients

The absence or dysfunction of the spleen is associated with a substantially increased risk of invasive infections that may rapidly progress to fulminant sepsis, including overwhelming post-splenectomy infection (OPSI), a medical emergency with high mortality. Although the risk is greatest in the first two years after splenectomy, it persists lifelong. Preventing infections in patients with anatomical or functional asplenia requires an integrated strategy that includes patient education, early recognition of symptoms, behavioral measures, antibiotic prophylaxis when indicated, and vaccination. Post-splenectomy immunization has been shown to reduce OPSI incidence. Regional and international guidelines recommend vaccination against pneumococcus, Haemophilus influenzae type b, meningococcus (B and ACWY), herpes zoster, diphtheria-tetanus-pertussis, measles-mumps-rubella-varicella, and annual influenza. However, adherence to these recommendations is frequently suboptimal, often due to limited awareness among patients and healthcare professionals. This study involves the intra-hospital vaccination team providing structured vaccination consultations to splenectomized patients hospitalized at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS. During ward consultations, patients receive an educational intervention on asplenia-related infectious risks and preventive measures, supported by standardized informational materials. Effectiveness is evaluated using a pre-post questionnaire assessing knowledge and awareness. Patients completing the vaccination pathway at the outpatient clinic also complete a questionnaire assessing their experience with vaccination management in an intra-hospital setting.

NCT Number	NCT07354893
Lead Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions	Splenectomized Patients, Splenectomy, Splenectomy; Status, Asplenia
Enrollment	100 participants
Start Date	2026-01-13
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-01-13 (estimated)
Updated on ClinicalTrials.gov	2026-02-02