Ethics, NarrativeNCT04664452
Current Status of Porcine Derived Products in Surgery
An observational study of Ethics, Narrative, run by Ankara University.
Trial summary
Porcine derived products are being used as biological grafts in mainly in orthopedic surgery, neurosurgery, cardiovascular surgery and general surgery. It is well known that consuming pork or porcine products are prohibited in some religions or divisions of religions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ethics, Narrative
- What is being tested?
- Questionnaire
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2021to 20 Sep 2021
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Specialist of any branch of surgery excluding pathology and anesthesiology
Who may be able to join
- Being volunteer and responder of at least 80% of the study questionnaire
Who cannot join
- Responding less than 80% of the questionnaire
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Current Status of Utilization an Surgeons' View of Porcine Derived Medical Products: an International Survey
Porcine derived products are being used as biological grafts in mainly in orthopedic surgery, neurosurgery, cardiovascular surgery and general surgery. It is well known that consuming pork or porcine products are prohibited in some religions or divisions of religions. It may be a tender point for patients undergoing surgery in which porcine derived products are utilized.In this survey study we aimed to determine the level of awareness and perception of surgeons with an international anquette. The study will also reveal the choices of surgeons about this issue both in elective and emergency procedures
Read the detailed description
In the survey study an online anquette form will be sent through online surgery networks both professional and social media. The questionnaire will not include questions defining the responders individually. The questions are related to frequency of utilization of porcine derived products in surgery, surgeons' level of awareness about utilization of porcine products, surgeons' level of religiousity and surgeons' choices about porcine derived product utilization and consent of patients. After collection of responses the data will be analyzed to discover current status of porcine derived surgical product utilization and surgeons' perception about the issue. The anquette will be distributed worldwide to surgeons in different branches of surgery. Literature seems to be lacking of that kind of study
- Conditions
- Ethics, Narrative
- Being tested
- Questionnaire
- Keywords
- porcine, ethics, informed consent, biological graft
- Medical subject headings
- Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Participants will be asked to fill the questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeons' awareness of utilization of porcine derived products in surgery
Frequency of awareness and experience on porcine derived medical products
Measured: 2 month
Surgeons' choice about utilization of porcine derived products in surgery
Choices of surgeons on specific scenarios in the questionnaire
Measured: 2 month
Secondary outcomes (2)
Relationship of porcine derived product utilization according to religious/phlosophical belief
Choices of surgeons according to Religiousness Scale of Altemayer
Measured: 2 month
Surgeons' choice about informing patients about porcine derived products
What ar e the choices of surgeons about informing patients and their relatives in described scenarios in the questionnaire
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start5 May 2021 (estimated)
- Primary completion20 Aug 2021 (estimated)
- Study completion20 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ethics, NarrativeStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvan Onur Kirimker, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664452
- Sponsor's protocol ID
- PORCINE2020
- Status last verified
- May 2021
- First submitted
- 6 Dec 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only study protocol and results will be shared on the clinicaltrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Status of Utilization an Surgeons' View of Porcine Derived Medical Products: an International Survey
- ClinicalTrials.gov ID
- NCT04664452
- Acronym / sponsor ID
- PORCINE2020
- Conditions
- Ethics, Narrative
- Keywords
- porcine, ethics, informed consent, biological graft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 5 May 2021 (estimated)
- Primary completion
- 20 Aug 2021 (estimated)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 11 Dec 2020 (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.
Porcine derived products are being used as biological grafts in mainly in orthopedic surgery, neurosurgery, cardiovascular surgery and general surgery. It is well known that consuming pork or porcine products are prohibited in some religions or divisions of religions. It may be a tender point for patients undergoing surgery in which porcine derived products are utilized.In this survey study we aimed to determine the level of awareness and perception of surgeons with an international anquette. The study will also reveal the choices of surgeons about this issue both in elective and emergency procedures
Detailed description
In the survey study an online anquette form will be sent through online surgery networks both professional and social media. The questionnaire will not include questions defining the responders individually. The questions are related to frequency of utilization of porcine derived products in surgery, surgeons' level of awareness about utilization of porcine products, surgeons' level of religiousity and surgeons' choices about porcine derived product utilization and consent of patients. After collection of responses the data will be analyzed to discover current status of porcine derived surgical product utilization and surgeons' perception about the issue. The anquette will be distributed worldwide to surgeons in different branches of surgery. Literature seems to be lacking of that kind of study
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Specialist of any branch of surgery excluding pathology and anesthesiology
Key inclusion criteria (1 listed)
- Being volunteer and responder of at least 80% of the study questionnaire
Key exclusion criteria (1 listed)
- Responding less than 80% of the questionnaire
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 |
|---|---|---|
| QuestionnaireParticipants will be asked to fill the questionnaire | Other | – |
Primary outcome
Surgeons' awareness of utilization of porcine derived products in surgery
Time frame: 2 month
Frequency of awareness and experience on porcine derived medical products
Surgeons' choice about utilization of porcine derived products in surgery
Time frame: 2 month
Choices of surgeons on specific scenarios in the questionnaire
2 secondary outcomes
Relationship of porcine derived product utilization according to religious/phlosophical belief
Time frame: 2 month
Surgeons' choice about informing patients about porcine derived products
Time frame: 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only study protocol and results will be shared on the clinicaltrials.gov
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ethics, Narrative, run by Ankara University.
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 1 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: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elvan Onur Kirimker (905327318075, kirimker@ankara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeons' awareness of utilization of porcine derived products in surgery (time frame: 2 month). The study lists 2 primary outcomes in all. 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 6 May 2021.