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

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



Sponsors


Source

Epsom and St Helier University Hospitals NHS Trust

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Detailed Description

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

Overall Status

Not yet recruiting

Start Date

2018-07-01

Completion Date

2019-07-01

Primary Completion Date

2019-03-01

Study Type

Observational

Primary Outcome

Measure

Time Frame

Women's Knowledge and Attitudes to Use of Mesh in Gynaecological Surgery
Duration of study, 12 months

Number Of Groups

1

Enrollment

150

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

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.

Arm Group Label

Women attending gynaecology clinics


Eligibility

Study Pop

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

Sampling Method

Non-Probability Sample

Criteria

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.

Exclusion Criteria:

1. Patient refusal.

2. Inability to consent due to a language barrier (no translator available, medication)

Gender

Female

Gender Based

Yes

Gender Description

Female patients attending gynaecology clinic

Minimum Age

18 Years

Maximum Age

N/A


Verification Date

2018-01-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Women attending gynaecology clinics

Description

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


Firstreceived Results Date

N/A

Reference

Citation

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


Citation

Dällenbach 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


Citation

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


Citation

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

PMID

21857223


Citation

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. Review. Update in: Cochrane Database Syst Rev. 2016 Nov 30;11:CD004014.

PMID

23633316



Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Other

Time Perspective

Prospective


Study First Submitted

May 4, 2018

Study First Submitted Qc

May 15, 2018

Study First Posted

May 16, 2018

Last Update Submitted

May 16, 2018

Last Update Submitted Qc

May 16, 2018

Last Update Posted

May 18, 2018


ClinicalTrials.gov processed this data on May 18, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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