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

July 5, 2019 updated by: Adnan Orhan, Uludag University

Social Media Awareness Level of Non-urogynecologist Doctors About the Current Mesh Discussions in Urogynecology: A Practical Survey Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ozluce
      • Bursa, Ozluce, Turkey, 16059
        • Recruiting
        • Uludag University Hospital, Department of Obstetrics and Gynecology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Collaborators

King's College Hospital NHS Trust

Investigators

  • Study Director: Kemal Ozerkan, M.D., Uludag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 15, 2019

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 8, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU-SUAM-MREC-2018-13/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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