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出境医 / 临床实验 / Mesh Debate Awareness Among Non-urogynecologists. A Practical Survey Study. (Mesh_Survey)
Mesh Debate Awareness Among Non-urogynecologists. A Practical Survey Study. (Mesh_Survey)
Study Description
Brief Summary:
This study evaluates the awareness of mesh discussions in urogynecology among non-urogynecologists. A web-based questionnaire will be sent to four groups. Group-1 is King's College Hospital doctors. Group-2 is Uludag University Hospital doctors. Group-3 is doctors from the United States, and Group-4 is doctors from all over the world.
| Condition or disease | Intervention/treatment |
|---|---|
| Pelvic Organ Prolapse Urinary Incontinence Complication of Surgical Procedure | Other: Mesh debate awareness survey |
Detailed Description:
There has been a great deal of discussion about mesh complications in urogynecology. During the following decade, vaginal mesh operations for pelvic organ prolapse increased exponentially all over the world, particularly in the United States. Once the complications started to increase, the publication of mesh-related complications on social and broadcast media and the increase of medico-legal claims the United States led to an extensive FDA (Food and Drug Administration) restriction on vaginal mesh procedures in 2013. On January 5, 2016, the FDA reclassified surgical mesh for transvaginal repair of the pelvic organ prolapse into class III, which require premarket approval. Finally, on April 16, 2019, the FDA ordered all manufacturers of urogynecological mesh intended for transvaginal repair to stop selling and distributing their products immediately. However, awareness of the other doctors in branches of medicine outside of gynecology and urology is unknown.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 1500 participants |
| Observational Model: | Other |
| Time Perspective: | Other |
| Official Title: | Social Media Awareness Level of Non-urogynecologist Doctors About the Current Mesh Discussions in Urogynecology: A Practical Survey Study. |
| Actual Study Start Date : | March 1, 2019 |
| Estimated Primary Completion Date : | September 1, 2019 |
| Estimated Study Completion Date : | September 15, 2019 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Group-1: King's College Hospital
Doctors in King's College Hospital, London, The United Kingdom (Excluding Urology and Gynecology)
|
Other: Mesh debate awareness survey
A web-based questionnaire with questions about recent discussions of mesh in urogynecology. 10 questions. Average survey completion time: 1 minute |
|
Group-2: Uludag University Hospital
Doctors in Uludag University Hospital, Bursa, Turkey (Excluding Urology and Gynecology)
|
Other: Mesh debate awareness survey
A web-based questionnaire with questions about recent discussions of mesh in urogynecology. 10 questions. Average survey completion time: 1 minute |
|
Group-3: The United States
Doctors from The United States (Excluding Urology and Gynecology)
|
Other: Mesh debate awareness survey
A web-based questionnaire with questions about recent discussions of mesh in urogynecology. 10 questions. Average survey completion time: 1 minute |
|
Group-4: The World
Doctors from all over the world (Excluding Urology and Gynecology)
|
Other: Mesh debate awareness survey
A web-based questionnaire with questions about recent discussions of mesh in urogynecology. 10 questions. Average survey completion time: 1 minute |
Outcome Measures
Primary Outcome Measures :
- Awareness of the current mesh discussion in urogynecology. [ Time Frame: 1 minute ]Web-based survey about current mesh discussion in Urogynecology with ten simple questions will be answered by the doctors in four groups (Question-8).
Secondary Outcome Measures :
- Social media awareness about the mesh discussions in urogynecology [ Time Frame: 1 minute ]Web-based survey about current mesh discussion in Urogynecology with ten simple questions will be answered by the doctors in four groups (Question-10).
Eligibility Criteria
| Ages Eligible for Study: | 30 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Doctors from four different groups (1-KCH, 2-UUH, 3-USA, 4-WORLD) are expected to complete the questionnaire.
Criteria
Inclusion Criteria:
- Doctors from all branches of medicine
- Basic sciences: Immunology, Medical Biochemistry, Microbiology and Infectious Diseases, Forensic Medicine, Family Medicine, Public Health, Medical genetics, Medical pharmacology.
- Pediatrics: Pediatric allergy, Pediatric respiratory, Pediatric dentistry, Pediatric endocrinology, Pediatric gastroenterology and nutrition, Pediatric haematology, Pediatric nephrology, Pediatric neurology, Pediatric oncology, Pediatric ophthalmology, Pediatric surgery, Child and adolescent psychiatry, Pediatric orthopedics.
- Basic internal medicine specialties: Gastroenterology, Medical Oncology, Rheumatology, Hematology, Nephrology, Endocrinology
- Other internal medicine specialties: Neurology, Nuclear medicine, Radiology, Radiation Oncology, Psychiatry, Sport medicine, Respiratory medicine, Physical medicine and rehabilitation, Geriatrics, Dermatology, Cardiology
- Surgical Departments: Emergency and Accident Medicine, Heart and vascular surgery, Ophthalmatology, Orthopedics and Traumatology, Plastic and reconstructive surgery, Medical pathology, Anesthesiology and reanimation, Neurosurgery, General surgery, Chest surgery
Exclusion Criteria:
- Obstetricians and Gynaecologists,
- Urogynecologists,
- Urologists,
- Perinatologists ,
- Gynecological Oncologists,
- Doctors from Reproductive Endocrinology and Infertility,
- Uro-oncologists
- Andrologists.
Contacts and Locations
Contacts
| Contact: Adnan Orhan, M.D. | +905056337102 | dr.adnan.orhan@hotmail.com | |
| Contact: Angela Rantell, PhD | +44 (0)20 3299 3568 | angela.rantell@nhs.net |
Locations
| Turkey | |
| Uludag University Hospital, Department of Obstetrics and Gynecology | Recruiting |
| Bursa, Ozluce, Turkey, 16059 | |
| Contact: Adnan Orhan, M.D. +90 505 6337102 dr.adnan.orhan@hotmail.com | |
| Contact: Isil Kasapoglu, M.D +905305455848 kasapogluisil@hotmail.com | |
Sponsors and Collaborators
Uludag University
King's College Hospital NHS Trust
Investigators
| Study Director: | Kemal Ozerkan, M.D. | Uludag University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 2, 2019 | ||||||||
| First Posted Date | July 8, 2019 | ||||||||
| Last Update Posted Date | July 9, 2019 | ||||||||
| Actual Study Start Date | March 1, 2019 | ||||||||
| Estimated Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Awareness of the current mesh discussion in urogynecology. [ Time Frame: 1 minute ] Web-based survey about current mesh discussion in Urogynecology with ten simple questions will be answered by the doctors in four groups (Question-8).
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
Social media awareness about the mesh discussions in urogynecology [ Time Frame: 1 minute ] Web-based survey about current mesh discussion in Urogynecology with ten simple questions will be answered by the doctors in four groups (Question-10).
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Mesh Debate Awareness Among Non-urogynecologists. A Practical Survey Study. | ||||||||
| Official Title | Social Media Awareness Level of Non-urogynecologist Doctors About the Current Mesh Discussions in Urogynecology: A Practical Survey Study. | ||||||||
| Brief Summary | This study evaluates the awareness of mesh discussions in urogynecology among non-urogynecologists. A web-based questionnaire will be sent to four groups. Group-1 is King's College Hospital doctors. Group-2 is Uludag University Hospital doctors. Group-3 is doctors from the United States, and Group-4 is doctors from all over the world. | ||||||||
| Detailed Description | There has been a great deal of discussion about mesh complications in urogynecology. During the following decade, vaginal mesh operations for pelvic organ prolapse increased exponentially all over the world, particularly in the United States. Once the complications started to increase, the publication of mesh-related complications on social and broadcast media and the increase of medico-legal claims the United States led to an extensive FDA (Food and Drug Administration) restriction on vaginal mesh procedures in 2013. On January 5, 2016, the FDA reclassified surgical mesh for transvaginal repair of the pelvic organ prolapse into class III, which require premarket approval. Finally, on April 16, 2019, the FDA ordered all manufacturers of urogynecological mesh intended for transvaginal repair to stop selling and distributing their products immediately. However, awareness of the other doctors in branches of medicine outside of gynecology and urology is unknown. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Other |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Doctors from four different groups (1-KCH, 2-UUH, 3-USA, 4-WORLD) are expected to complete the questionnaire. | ||||||||
| Condition |
|
||||||||
| Intervention | Other: Mesh debate awareness survey
A web-based questionnaire with questions about recent discussions of mesh in urogynecology. 10 questions. Average survey completion time: 1 minute |
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| Study Groups/Cohorts |
|
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 15, 2019 | ||||||||
| Estimated Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 30 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | Turkey | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04010162 | ||||||||
| Other Study ID Numbers | UU-SUAM-MREC-2018-13/11 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | Adnan Orhan, Uludag University | ||||||||
| Study Sponsor | Uludag University | ||||||||
| Collaborators | King's College Hospital NHS Trust | ||||||||
| Investigators |
|
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| PRS Account | Uludag University | ||||||||
| Verification Date | July 2019 | ||||||||
