Clinical trial NCT07027371: Post Splenectomy Care Assessment and the Role of Patient Education in Its Improvement
Official title: Evaluation of Care Provided for Splenectomized Children and the Role of Patients' Education in Its Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Splenectomized Patients
Keywords: Overwhelming post splenectomy infections
splenectomy
chemoprophylaxis
vaccination
encapsulated organisms
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this trial is to evaluate compliance to booster vaccines and chemoprophylaxis in children who underwent a splenectomy and to assess the knowledge regarding this aspect before and after giving education.

Detailed description: The term "overwhelming post-splenectomy infection" (OPSI) refers to a rapid fatal syndrome occurring in individuals following removal of the spleen. OPSI can progress from a mild flu-like illness to fulminant sepsis in a short time period and has high mortality rate despite maximal treatment. The mainstays of infectious diseases prevention in asplenic subjects include: 1) patient and family education, 2) vaccinations, 3) prophylactic antimicrobial therapy in selected people, 4) early empirical antimicrobial therapy for febrile episodes, 5) early management of animal bites. Studies demonstrated that patients were neither compliant to postsplenectomy booster vaccines nor chemoprophylaxis with oral penicillin. Inadequate information and lack of sufficient education seem to be the major culprit behind this lack of awareness.

The study will be carried out at the Pediatric Hematology Clinic, Cairo University Children Hospital.

Candidates will be given questionnaires that will inquire about education level, disease type, age, duration of illness, age at splenectomy, duration of splenectomy , reception of preoperative vaccines (Pneumococcal, Hemophilus, Meningococcal vaccines) , compliance to postsplenectomy booster doses and penicillin prophylaxis , and if not what are the reasons for that.

Patients will also be given written information educating them about OPSI, its red flags and the importance of post splenectomy care. Interview questionnaire will be given to patients before and after education.

Eligibility criteria: Inclusion Criteria:

* Patients above 15 years who had undergone splenectomy
* Caregivers of patients aged below 15 years who had undergone splenectomy

Exclusion Criteria:

* Illiterate candidates
* Candidates who refuse to take part in the study

Primary outcomes:
measure: Candidates' knowledge about the different aspects of post splenectomy hazards and methods of care
timeFrame: At baseline and immediately after intervention
Secondary outcomes:
measure: To detect the rate of vaccination (defined as the percentage of people who have received vaccines) to pneumococcal, meningococcal and hemophilus influenza vaccine among the studied population (splenectomized patients).
timeFrame: At time of enrollment in the study
measure: To detect the percentage of patients who received post splenectomy chemoprophylaxis among the studied population.
timeFrame: At time of enrollment in the study
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Pediatrics, Faculty of Medicine, Cairo University
Study officials:
References: