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临床试验/NCT03527082
NCT03527082Unknown不适用

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

Epsom and St Helier University Hospitals NHS Trust0 个研究点目标入组 150 人开始时间: 2018年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
Women's Knowledge and Attitudes to Use of Mesh in Gynaecological Surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: Duration of study, 12 months

Assessed by use of questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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