Splenectomy; StatusNCT07428005
Development of an Italian Questionnaire for Splenectomized Patients Using a Delphi Consensus Method
An observational study of Splenectomy; Status and Asplenia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This study aims to develop an Italian-language questionnaire assessing awareness, knowledge of infectious risk prevention strategies, and vaccination attitudes among splenectomized individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Splenectomy; Status, Asplenia, Splenectomized Patients
- What is being tested?
- Delphi Consensus Process
- Type of treatment
- Vaccines
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2026to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of a multidisciplinary panel of healthcare professionals, including physicians, nurses, and healthcare assistants working at Fondazione Policlinico Universitario A. Gemelli IRCCS, with clinical or academic experience in vaccination and infection prevention, particularly in the management of patients with asplenia. Participants are selected to ensure representation from different specialties involved in the care of asplenic patients and will participate in a Delphi consensus process aimed at developing a questionnaire on infectious risk prevention awareness and vaccination attitudes.
Who may be able to join
- Healthcare professionals working at Fondazione Policlinico Universitario A. Gemelli IRCCS
- Professional experience in vaccination or infection prevention
- Clinical involvement in care of patients with asplenia or related conditions
- Italian native language proficiency
- Provision of informed consent
Who cannot join
- Participation in the expert panel is restricted to individuals who meet all predefined inclusion criteria. Failure to satisfy any inclusion criterion automatically results in exclusion from the study population
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
Patrizia Laurenti, Professor, +390630155701, patrizia.laurenti@policlinicogemelli.it
Patrizia Laurenti
About this study
Official title: Development of an Italian Questionnaire to Assess Awareness and Knowledge of Infectious Risk Prevention Strategies in Splenectomized Patients Using a Delphi Consensus Method
This study aims to develop an Italian-language questionnaire assessing awareness, knowledge of infectious risk prevention strategies, and vaccination attitudes among splenectomized individuals. The questionnaire will be developed through a structured Delphi consensus process involving a multidisciplinary panel of healthcare professionals experienced in infection prevention and vaccination strategies. Two Delphi rounds will be conducted online to evaluate item relevance and clarity. Items reaching predefined consensus thresholds will be included in the final questionnaire. The resulting tool will support future studies assessing preventive care awareness and vaccination uptake among splenectomized patients.
Read the detailed description
Individuals without a functioning spleen face a lifelong increased risk of severe infections, particularly from encapsulated bacteria. Preventive strategies include vaccination, antibiotic prophylaxis, and patient education. However, adherence to preventive measures remains suboptimal, partly due to limited awareness and knowledge among patients.
This study aims to develop a validated Italian-language questionnaire to assess awareness, knowledge of preventive strategies, and attitudes toward vaccination among splenectomized individuals.
A modified Delphi consensus methodology will be used. A multidisciplinary panel of healthcare professionals involved in managing asplenic patients will be recruited. Following a preliminary literature scoping review, draft questionnaire items will be generated and submitted to two Delphi rounds conducted online.
Participants will rate each item for relevance and clarity using structured Likert scales. Items reaching predefined consensus thresholds will be retained and refined between rounds. The final questionnaire will consist only of items achieving expert consensus.
The study does not involve patients directly and poses minimal risk, as participation is voluntary and responses are anonymized.
- Conditions
- Splenectomy; Status, Asplenia, Splenectomized Patients
- Being tested
- Delphi Consensus Process
- Keywords
- splenectomy, asplenia, vaccination, infection prevention, delphi study, questionnaire development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi Consensus ProcessOther
A structured Delphi consensus process involving a multidisciplinary panel of healthcare professionals aimed at developing and validating questionnaire items assessing awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals. Participants evaluate questionnaire items across two online Delphi rounds, rating relevance and clarity. Items reaching predefined consensus thresholds are retained to produce the final questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a consensus-based questionnaire for assessing awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals.
The outcome consists of the development of a finalized Italian questionnaire through a Delphi consensus process. As this outcome refers to the creation of a new instrument within the study, no scoring system, scale range, or interpretation of scores is applicable at this stage.
Measured: At study completion (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jan 2026
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenectomy; StatusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurenti Patrizia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- LAURENTI PATRIZIA, PROFESSOR, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428005
- Sponsor's protocol ID
- 8121
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Italian Questionnaire to Assess Awareness and Knowledge of Infectious Risk Prevention Strategies in Splenectomized Patients Using a Delphi Consensus Method
- ClinicalTrials.gov ID
- NCT07428005
- Acronym / sponsor ID
- 8121
- Conditions
- Splenectomy; Status, Asplenia, Splenectomized Patients
- Keywords
- splenectomy, asplenia, vaccination, infection prevention, delphi study, questionnaire development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 23 Feb 2026 (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.
This study aims to develop an Italian-language questionnaire assessing awareness, knowledge of infectious risk prevention strategies, and vaccination attitudes among splenectomized individuals. The questionnaire will be developed through a structured Delphi consensus process involving a multidisciplinary panel of healthcare professionals experienced in infection prevention and vaccination strategies. Two Delphi rounds will be conducted online to evaluate item relevance and clarity. Items reaching predefined consensus thresholds will be included in the final questionnaire. The resulting tool will support future studies assessing preventive care awareness and vaccination uptake among splenectomized patients.
Detailed description
Individuals without a functioning spleen face a lifelong increased risk of severe infections, particularly from encapsulated bacteria. Preventive strategies include vaccination, antibiotic prophylaxis, and patient education. However, adherence to preventive measures remains suboptimal, partly due to limited awareness and knowledge among patients.
This study aims to develop a validated Italian-language questionnaire to assess awareness, knowledge of preventive strategies, and attitudes toward vaccination among splenectomized individuals.
A modified Delphi consensus methodology will be used. A multidisciplinary panel of healthcare professionals involved in managing asplenic patients will be recruited. Following a preliminary literature scoping review, draft questionnaire items will be generated and submitted to two Delphi rounds conducted online.
Participants will rate each item for relevance and clarity using structured Likert scales. Items reaching predefined consensus thresholds will be retained and refined between rounds. The final questionnaire will consist only of items achieving expert consensus.
The study does not involve patients directly and poses minimal risk, as participation is voluntary and responses are anonymized.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of a multidisciplinary panel of healthcare professionals, including physicians, nurses, and healthcare assistants working at Fondazione Policlinico Universitario A. Gemelli IRCCS, with clinical or academic experience in vaccination and infection prevention, particularly in the management of patients with asplenia. Participants are selected to ensure representation from different specialties involved in the care of asplenic patients and will participate in a Delphi consensus process aimed at developing a questionnaire on infectious risk prevention awareness and vaccination attitudes.
Key inclusion criteria (5 listed)
- Healthcare professionals working at Fondazione Policlinico Universitario A. Gemelli IRCCS
- Professional experience in vaccination or infection prevention
- Clinical involvement in care of patients with asplenia or related conditions
- Italian native language proficiency
- Provision of informed consent
Key exclusion criteria (1 listed)
- Participation in the expert panel is restricted to individuals who meet all predefined inclusion criteria. Failure to satisfy any inclusion criterion automatically results in exclusion from the study population
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 |
|---|---|---|
| Delphi Consensus ProcessA structured Delphi consensus process involving a multidisciplinary panel of healthcare professionals aimed at developing and validating questionnaire items assessing awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals. Participants evaluate questionnaire items across two online Delphi rounds, rating relevance and clarity. Items reaching predefined consensus thresholds are retained to produce the final questionnaire. | Other | – |
Primary outcome
Development of a consensus-based questionnaire for assessing awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals.
Time frame: At study completion (4 months)
The outcome consists of the development of a finalized Italian questionnaire through a Delphi consensus process. As this outcome refers to the creation of a new instrument within the study, no scoring system, scale range, or interpretation of scores is applicable at this stage.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Splenectomy; Status
Not yet recruitingObservational study
Effect of Laparoscopic Splenectomy on Renal Function in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up)
Cirrhosis, Splenectomy; Status
Not yet recruitingObservational study
Effect of LSD on Renal Function in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up)
Cirrhosis, Liver, Splenectomy; Status
Not yet recruitingObservational study
Effect of LSD on Lipid Profiles in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up)
Cirrhosis, Liver, Splenectomy; Status
Not yet recruitingObservational study
Effect of Laparoscopic Splenectomy on Lipid Profiles in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up)
Cirrhosis, Splenectomy; Status
RecruitingObservational study
Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients
Splenectomized Patients, 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.
LAURENTI PATRIZIA, PROFESSOR principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Splenectomy; Status and Asplenia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LAURENTI PATRIZIA, PROFESSOR (0630159333, patrizia.laurenti@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a consensus-based questionnaire for assessing awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals. (time frame: At study completion (4 months)). 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 8 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.