Women's Knowledge and Attitudes to Use of Mesh in Gynaecological Surgery

NCT03527082 | Unknown

• 1 other identifier: IRAS ID 241922
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a questionnaire study that is being performed to ascertain the knowledge and attitudes of women towards use of mesh in gynaecological surgery. Women over the age of 18, able to read and comprehend the information leaflet, sign and give informed consent will be eligible to participate. Women who are not fluent in English will be able to participate if a translator can convey the information. The trial will be conducted at Epsom and St Helier Hospitals, in the United Kingdom. The investigators aim to recruit 150 women to this study. No power calculation has been performed as this is an exploratory study. However, previous studies have included 64 and 77 women respectively.

Conditions

Prolapse, Vaginal

Keywords

mesh; erosion; transvaginal; prolapse; laparoscopic; tension free tape

Outcome Measures

Primary Outcomes (1)

• Women's Knowledge and Attitudes to Use of Mesh in Gynaecological Surgery

  Assessed by use of questionnaire

  Duration of study, 12 months

Study Arms (1)

Women attending gynaecology clinics

150 women attending gynaecology clinics that fulfil inclusion criteria Inclusion criteria: Inclusion criteria 1. Over the age of 18 2. attending gynaecology clinics 3. Able to read and comprehend the details of the study in patient information sheet. 4. Mentally competent at signing the consent form. 5. English -speaking, if not then translator available

Other: Questionnaire

Interventions

Questionnaire OTHER

Questionnaire of 20 items evaluating attitudes and perception of mesh use in gynaecological surgery. Questionnaire will take 10 minutes to complete. For non-English speaking patients a translator will be sought, where feasible to help women complete the questionnaire. Participation will be entirely voluntary and also the questionnaire will be piloted to ensure that questions asked are clear and concise. Questionnaire is anonymised and does not contain patient identifying information thereby eliminating breach of confidentiality.

Women attending gynaecology clinics

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients attending gynaecology clinic
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women attending gynaecology outpatient clinics at Epsom and St Helier's University Hospitals

You may qualify if:

• a. Women \> 18 years of age attending gynaecology clinics
• b. Able to read and comprehend the details of the study in patient information sheet.
• c. Mentally competent at signing the consent form.

You may not qualify if:

• Patient refusal.
• Inability to consent due to a language barrier (no translator available, medication)

Sponsors & Collaborators

• Epsom and St Helier University Hospitals NHS Trust: lead

Related Publications (5)

• Brown LK, Fenner DE, Berger MB, Delancey JO, Morgan DM, Patel DA, Schimpf MO. Defining patients' knowledge and perceptions of vaginal mesh surgery. Female Pelvic Med Reconstr Surg. 2013 Sep-Oct;19(5):282-7. doi: 10.1097/SPV.0b013e31829ff765.

  PMID: 23982577 BACKGROUND

• Dallenbach P, De Oliveira SS, Marras S, Boulvain M. Incidence and risk factors for mesh erosion after laparoscopic repair of pelvic organ prolapse by lateral suspension with mesh. Int Urogynecol J. 2016 Sep;27(9):1347-55. doi: 10.1007/s00192-016-2974-z. Epub 2016 Feb 17.

  PMID: 26886554 BACKGROUND

• Dessie SG, Hacker MR, Haviland MJ, Rosenblatt PL. Attitudes toward transvaginal mesh among patients in a urogynecology practice. Int Urogynecol J. 2015 Jun;26(6):865-73. doi: 10.1007/s00192-014-2607-3. Epub 2015 Jan 17.

  PMID: 25595568 BACKGROUND

• Iglesia CB. Synthetic vaginal mesh for pelvic organ prolapse. Curr Opin Obstet Gynecol. 2011 Oct;23(5):362-5. doi: 10.1097/GCO.0b013e32834a92ab.

  PMID: 21857223 BACKGROUND

• Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.

  PMID: 23633316 BACKGROUND

Related Links

• National Institute for Health and Care Excellence. Transvaginal meshes for anterior and posterior prolapse. 2017

MeSH Terms

Conditions

Uterine Prolapse; Prolapse

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 16, 2018
• Study Start: July 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 18, 2018

Record last verified: 2018-01