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Completed

NCT Number: NCT07027371

Post Splenectomy Care Assessment and the Role of Patient Education in Its Improvement

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics, Faculty of Medicine, Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Education

Behavioral

Health education was given in the form of a printed colored brochure designed in easy-to-understand Arabic language. Participants were encouraged to read the brochure thoroughly and as many times as needed and to ask questions to the researchers if they had any.

Primary outcomes

  1. Candidates' knowledge about the different aspects of post splenectomy hazards and methods of care

    Time frame: At baseline and immediately after intervention

    A questionnaire designed by the hematology team inquiring about different aspects of post splenectomy hazards and methods of care was handed to candidates. Each correct answer was given a score of 1. A score was summed up and a total score (as a percentage of correct answers) was given.

Secondary outcomes

  1. 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).

    Time frame: At time of enrollment in the study

    This was achieved through a questionnaire inquiring about the reception of pneumococcal, meningococcal and hemophilus influenza vaccine among other data designed and given to candidates.

  2. To detect the percentage of patients who received post splenectomy chemoprophylaxis among the studied population.

    Time frame: At time of enrollment in the study

    This was achieved through a questionnaire inquiring about the reception of chemoprophylaxis, handed to the candidates.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Care Provided for Splenectomized Children and the Role of Patients' Education in Its Improvement

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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