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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Laparoscopic Lateral Mesh Suspension for Pelvic Organ Prolapse

NCT03387202

Pelvic Organ Prolapse Pelvic Floor Prolapse

COMPLETED

Four-arm Mesh for Vaginal Stump Prolapse

NCT03809806

Pelvic Organ Prolapse Sexual Function Abnormal

COMPLETED NA

Comparison of Mesh-Based and Mesh-Free Laparoscopic Pectopexy in Uterus-Preserving Surgery for Apical Prolapse

NCT07080957

Pelvic Organ Prolapse

COMPLETED NA

A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

NCT04358978

Pelvic Organ Prolapse

UNKNOWN NA

The Follow-up of Mesh/Native Tissue Complications Study(Part I)

NCT03620565

Pelvic Floor

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common conditions experienced by women. It is estimated that 20% of women undergo surgery for the treatment of prolapse. Transvaginal placement of surgical mesh for repair of POP and SUI are associated with complications such as erosion, infection, dyspareunia, bowel and bladder perforation as well as failure of the operation. Such complications have resulted in the FDA reclassifying transvaginal meshes to high risk medical devices. Most recently, National Institute for Clinical Excellence (NICE) in the United Kingdom has limited the use of transvaginal meshes for anterior and posterior compartment prolapse to a research context only.

Since the FDA and NICE publications, there has been much controversy and increasing litigation arising from complications of transvaginal mesh use. Recent negative media attention has likely affected patients' perception regarding mesh use in gynaecology. There are no studies assessing the knowledge and perception of mesh use in gynaecological surgery within the United Kingdom. Previous studies have found patients have limited knowledge and often are misinformed. However, these have been limited to transvaginal meshes. Laparoscopic procedures using mesh for POP such as sacrohysteropexy and sacrocolpopexy are become increasingly popular with comparable outcomes to vaginal surgery. The risk of mesh erosion with laparoscopic surgery is less than vaginal placement.

The use of mesh of gynaecology remains a topical issues and given the amount of information available to patients, this concept merits study, as it may influence patients' decision making and therefore a prominent part of the consent process. The use of mesh in gynaecological surgery remains a highly effective method of treating POP and SUI in appropriately selected patients and routes. It is therefore important to understand patients' understanding and perception regarding mesh use and sources of information in the wake of media coverage and attention. The investigators seek to evaluate patients' knowledge and attitudes towards use of mesh in gynaecological surgery presenting to gynaecology clinics.

The investigators aim to survey 150 women attending gynaecology clinics using a questionnaire. A power calculation has not been performed however, similar studies have included 164 and 77 women respectively. The questionnaire consists of 20 questions that should take 10 minutes to complete.

Consent: A valid consent with detailed written information sheet will be sought before including them in this trial.

Inclusion and exclusion criteria: All women attending the clinic will be eligible to participate if they are over the age of 18, with an understanding of English or translator available and able to provide informed consent.

Risks and benefits: All women will receive the same standard of care regardless if they agree to disagree to participate in the trial. There are no disadvantages associated with participation in taking part in the study.

Data storage: All the information obtained from this study will be stored in a confidential manner and will only be available to the researchers for future analysis.Participants can withdraw their consent at any point and this will not affect the standard of care given to them in future.All the information pertaining to the trial will be destroyed securely.

This research does not involve any use, storage of any tissue

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prolapse, Vaginal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Questionnaire

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.