Splenectomized PatientsNCT07027371
Post Splenectomy Care Assessment and the Role of Patient Education in Its Improvement
A study testing Health education in people with Splenectomized Patients, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Splenectomized Patients
- What is being tested?
- Health education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients above 15 years who had undergone splenectomy
- Caregivers of patients aged below 15 years who had undergone splenectomy
Who cannot join
- Illiterate candidates
- Candidates who refuse to take part in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Pediatrics, Faculty of Medicine, Cairo University
Cairo
About this study
Official title: Evaluation of Care Provided for Splenectomized Children and the Role of Patients' 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.
Read the 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.
- Conditions
- Splenectomized Patients
- Being tested
- Health education
- Keywords
- Overwhelming post splenectomy infections, splenectomy, chemoprophylaxis, vaccination, encapsulated organisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Splenectomized patients above 15 years and caregivers of patients below 15 years received a questionnaire that included questions enquiring about age, gender, education level, disease type, duration of illness, age at splenectomy, duration since splenectomy, reception of preoperative vaccines, compliance to post splenectomy booster doses and penicillin prophylaxis, and the reasons for non-compliance if any, and their perception regarding red flags of Overwhelming Post Splenectomy Infection "OPSI". Based on the gaps of care identified in the essential questionnaire, educational material about perisplenectomy care was obtained. A knowledge test and a printed brochure were designed based on the knowledge script. Candidates who agreed to complete the study were asked to fill in individually the pre-education knowledge test. The brochures were then handed to each patient or caregiver. Participants were encouraged to read the brochure. Then they completed the post-education knowledge test Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Candidates' knowledge about the different aspects of post splenectomy hazards and methods of care
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.
Measured: At baseline and immediately after intervention
Secondary outcomes (2)
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).
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.
Measured: At time of enrollment in the study
To detect the percentage of patients who received post splenectomy chemoprophylaxis among the studied population.
This was achieved through a questionnaire inquiring about the reception of chemoprophylaxis, handed to the candidates.
Measured: At time of enrollment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start15 Dec 2021
- Primary completion18 Dec 2022
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenectomized PatientsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Saad Nassim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027371
- Sponsor's protocol ID
- MS-486-2021
- Status last verified
- Apr 2021
- First submitted
- 4 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the investigator on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Care Provided for Splenectomized Children and the Role of Patients' Education in Its Improvement
- ClinicalTrials.gov ID
- NCT07027371
- Acronym / sponsor ID
- MS-486-2021
- Conditions
- Splenectomized Patients
- Keywords
- Overwhelming post splenectomy infections, splenectomy, chemoprophylaxis, vaccination, encapsulated organisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: Health educationSplenectomized patients above 15 years and caregivers of patients below 15 years received a questionnaire that included questions enquiring about age, gender, education level, disease type, duration of illness, age at splenectomy, duration since splenectomy, reception of preoperative vaccines, compliance to post splenectomy booster doses and penicillin prophylaxis, and the reasons for non-compliance if any, and their perception regarding red flags of Overwhelming Post Splenectomy Infection "OPSI". Based on the gaps of care identified in the essential questionnaire, educational material about perisplenectomy care was obtained. A knowledge test and a printed brochure were designed based on the knowledge script. Candidates who agreed to complete the study were asked to fill in individually the pre-education knowledge test. The brochures were then handed to each patient or caregiver. Participants were encouraged to read the brochure. Then they completed the post-education knowledge test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients above 15 years who had undergone splenectomy
- Caregivers of patients aged below 15 years who had undergone splenectomy
Key exclusion criteria (2 listed)
- Illiterate candidates
- Candidates who refuse to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health educationHealth 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. | Behavioural | Interventional group |
Primary outcome
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.
2 secondary outcomes
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
To detect the percentage of patients who received post splenectomy chemoprophylaxis among the studied population.
Time frame: At time of enrollment in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the investigator on reasonable request
Related trials for Splenectomized Patients
RecruitingObservational study
Development of an Italian Questionnaire for Splenectomized Patients Using a Delphi Consensus Method
Splenectomy; Status, Asplenia
RecruitingObservational study
Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients
Splenectomized Patients, Splenectomy
RecruitingPhase 3
Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
Splenectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education in people with Splenectomized Patients, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Candidates' knowledge about the different aspects of post splenectomy hazards and methods of care (time frame: At baseline and immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.