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

NCT ID: NCT04010162

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-09-15

Brief Summary

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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

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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.

Conditions

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Pelvic Organ Prolapse Urinary Incontinence Complication of Surgical Procedure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Group-1: King's College Hospital

Doctors in King's College Hospital, London, The United Kingdom (Excluding Urology and Gynecology)

Mesh debate awareness survey

Intervention Type OTHER

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)

Mesh debate awareness survey

Intervention Type OTHER

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)

Mesh debate awareness survey

Intervention Type OTHER

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)

Mesh debate awareness survey

Intervention Type OTHER

A web-based questionnaire with questions about recent discussions of mesh in urogynecology.

10 questions. Average survey completion time: 1 minute

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role collaborator

Uludag University

OTHER

Sponsor Role lead

Responsible Party

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Adnan Orhan

Medical Doctor, Researcher, Obstetrician and Gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kemal Ozerkan, M.D.

Role: STUDY_DIRECTOR

Uludag University

Locations

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Uludag University Hospital, Department of Obstetrics and Gynecology

Bursa, Ozluce, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Adnan Orhan, M.D.

Role: CONTACT

+905056337102

Angela Rantell, PhD

Role: CONTACT

+44 (0)20 3299 3568

Facility Contacts

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Adnan Orhan, M.D.

Role: primary

+90 505 6337102

Isil Kasapoglu, M.D

Role: backup

+905305455848

References

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Lensen EJ, Withagen MI, Kluivers KB, Milani AL, Vierhout ME. Surgical treatment of pelvic organ prolapse: a historical review with emphasis on the anterior compartment. Int Urogynecol J. 2013 Oct;24(10):1593-602. doi: 10.1007/s00192-013-2074-2. Epub 2013 Mar 15.

Reference Type BACKGROUND
PMID: 23494056 (View on PubMed)

LANE FE. Repair of posthysterectomy vaginal-vault prolapse. Obstet Gynecol. 1962 Jul;20:72-7. doi: 10.1097/00006250-196207000-00009. No abstract available.

Reference Type BACKGROUND
PMID: 14462011 (View on PubMed)

Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016 Nov 30;11(11):CD004014. doi: 10.1002/14651858.CD004014.pub6.

Reference Type BACKGROUND
PMID: 27901278 (View on PubMed)

Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. doi: 10.1097/01.AOG.0000139514.90897.07.

Reference Type BACKGROUND
PMID: 15458906 (View on PubMed)

Other Identifiers

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UU-SUAM-MREC-2018-13/11

Identifier Type: -

Identifier Source: org_study_id

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