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Mesh Debate Awareness Among Non-urogynecologists. A Practical Survey Study. (Mesh_Survey)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010162
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
King's College Hospital NHS Trust
Information provided by (Responsible Party):
Adnan Orhan, Uludag University

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.

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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

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





Primary Outcome Measures :
  1. 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 :
  1. 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).



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010162


Contacts
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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
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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
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Study Director: Kemal Ozerkan, M.D. Uludag University
Publications:
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Responsible Party: Adnan Orhan, Medical Doctor, Researcher, Obstetrician and Gynecologist, Uludag University
ClinicalTrials.gov Identifier: NCT04010162    
Other Study ID Numbers: UU-SUAM-MREC-2018-13/11
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adnan Orhan, Uludag University:
mesh complications
social media awareness
knowledge of doctors
Additional relevant MeSH terms:
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Urinary Incontinence
Prolapse
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Pathological Conditions, Anatomical