Vaginoscopy Against Standard Treatment (VAST): a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Hysteroscopy success (composite primary outcome)
研究概览
简要总结
Inserting a telescope into the womb to identify and treat problems with bleeding, pain or reproduction is the commonest surgical intervention in gynaecology. This procedure is known as a 'hysteroscopy'. The established 'traditional' technique for introducing the hysteroscope into the womb involves the use of a 'speculum', which is inserted into the vagina. A speculum is the metal or plastic instrument used to stretch and separate the vaginal walls so that the opening to the womb, known as the 'cervix' can be seen. The cervix is then cleaned and frequently grasped with a sharp toothed forcep to provide traction before the hysteroscope is inserted. Whilst hysteroscopy is safe, it is known that pain during the procedure can lead to a poor patient experience, and even trigger fainting episodes or failure to complete the procedure. As the hysteroscopes have become smaller, it has been recognised that it is possible to access the cervix and womb (i.e. 'uterus') directly using the hysteroscopic vision without inserting any of these potentially pain inducing vaginal instruments. There is however, uncertainty whether this newer technique known as 'vaginoscopy' or the 'no touch technique' will minimise the pain experienced by the patient or reduce the propensity to fainting. Futhermore, even if vaginoscopy is shown to be less painful, the technique may be more prone to failure due to an inability to transverse the cervix and enter the uterus without additional instruments. Post-operative infection rates of the uterus may also be higher due to vaginal contamination.
Reducing pain and complications and improving success of the procedure as well as optimising patients experience is important because hysteroscopy is an intimate examination, known to be associated with significant anxiety and pain. Furthermore, the procedure is widely practised representing the most common surgical intervention in day-to-day gynaecological practice in the UK and elsewhere. It is therefore important, and timely given that outpatient hysteroscopy is increasing especially in community settings, that a large, high quality randomised controlled trial comparing 'vaginoscopy' and the 'traditional' hysteroscopy is undertaken to resolve the uncertainty as to whether vaginoscopy is less painful, safe and more successful than existing approaches to hysteroscopy.
详细描述
- Background
Office hysteroscopy can be associated with significant anxiety, pain and patient dissatisfaction (Clark et al.). One technical modification identified to potentially reduce pain at hysteroscopy is 'vaginoscopy', otherwise known as the 'no touch' technique (Busquets and Lemus, 1993; Clark and Gupta, 2005; Cooper et al., 2010). This describes a technique where the hysteroscope is guided into the uterus without the need for potentially painful vaginal instrumentation. Pain is often experienced by the patient at a number of stages during the standard hysteroscopy practice, these include passage of a vaginal speculum to separate the vaginal walls in order to visualise the cervix, cleansing of the cervix and sometimes application of traumatic forceps to the ectocervix in order to stabilise it. Vaginoscopy could be less traumatic because the approach minimises potentially painful manoeuvres in the lower genital tract.
Recent technological advances have led to the miniaturisation of hysteroscopes, which facilitates vaginoscopy by reducing resistance to advancement of the hysteroscope through the relatively narrow and often tortuous cervical canal. However, despite these modifications in instrumentation, few clinicians use vaginoscopy routinely preferring more invasive traditional approaches. This may reflect a lack of familiarity with the technique as well as concerns over the ability to identify and traverse the cervical canal in order to access the uterine cavity.
We therefore designed a randomised controlled trial (RCT) to compare standard approach to hysteroscopy against vaginoscopy evaluating important clinical outcomes such as pain, feasibility, acceptability, vasovagal responses and infection. To inform the study design we conducted pilot work including a survey of gynaecological endoscopists, and a systematic review of the current evidence. 2. Systematic review and meta-analysis
We have previously completed and reported a systematic review and meta-analysis of vaginoscopy compared to standard hysteroscopy (Cooper et al., 2010). The databases searched included MEDLINE, EMBASE, and CINAHL using a combination of the keyword 'hysteroscopy', 'vaginoscopy', vaginoscop*', 'no-touch', and their associated word variants and medical subject headings. The Cochrane Library was searched using the keywords 'hysteroscopy', 'vaginoscopy', 'vaginoscopic' and 'no-touch'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 16years or over
- •Referred for diagnostic of operative hysteroscopy in the outpatient setting
- •Written informed consent obtained prior to the hysteroscopy
排除标准
- •Need for hysteroscopic surgical intervention that requires cervical dilatation e.g. Novasure uterine ablation
结局指标
主要结局
Hysteroscopy success (composite primary outcome)
时间窗: At the time of surgery (day 1) for all elements except for infection (day 14)
The primary clinical outcome is a composite outcome of a completed hysteroscopy with an acceptable level of patient reported pain without a vasovagal episode or post-operative uterine infection. A composite outcome has been chosen as it was felt that all of these factors are important to classify a hysteroscopy as successful. See individual elements in secondary outcomes for a description of how they will be measured
次要结局
- Procedure Pain(At the time of surgery (day 1))
- Procedure failures(At the time of surgery (day 1))
- Vasovagal episodes(At the time of surgery (day 1))
- Infection rates(Two weeks post procedure (day 14))
研究者
Thomas Justin Clark
Consultant Obstetrician and Gynaecologist
Birmingham Women's NHS Foundation Trust