Vaginoscopy Against Standard Treatment (VAST): a Randomised Controlled Trial (VAST)

1. 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'.

Of the 1167 citations retrieved, six studies met the criteria for inclusion and in four there was suitable data for meta-analysis. Vaginoscopy was found to be less painful than traditional approaches, with a standard mean difference in visual analogue scales (VAS) pain scores of -0.44 (95% CI -0.65 to -0.22)(Cooper et al., 2010). However there was statistically significant heterogeneity and this was also seen in the wide variation in procedure feasibility (failure rates varying from 2% to 17%) (Cooper et al., 2010). This inconsistency reflected the lack of standardisation of approach both in relation to vaginoscopy and traditional speculum based approaches where there was variation between studies in the administration of local cervical anaesthesia, application of cervical tenaculum forceps, and the size and angle of the rigid hysteroscope employed. None of these small RCTs (Almeida et al., 2008; Garbin et al., 2006; Guida et al., 2006; Paschopoulos et al., 1997; Sagiv et al., 2006; Sharma et al., 2005) had optimal randomisation processes in terms of using computer generated random number sequences and third party concealment. The review and subsequent Royal College of Obstetrics and Gynaecology (RCOG) guideline (Clark et al.; Cooper et al., 2010) recommended further higher quality adequately powered RCTs to examine more comprehensively the role of vaginoscopy in terms of pain, feasibility, acceptability and complications. 3. The need for a RCT comparing vaginoscopy to standard hysteroscopy

The current restricted use of vaginoscopy is likely to be the result of a lack of experience with the technique and uncertainty as to whether the technique is associated with a worthwhile reduction in procedural pain and improvement in patient acceptability. Furthermore, there is concern that vaginoscopy is technically more challenging leading to prolonged procedures which may fail to be completed, lead to more vaso-vagal fainting episodes and a higher likelihood of post-operative infection of the uterus.

In view of the uncertainty over the effectiveness of vaginoscopy we designed an RCT. The aim was to evaluate whether vaginoscopy or standard hysteroscopy was potentially more successful in the office setting by comparing failure rates, complications, infection rates, patient acceptability, and pain scores. In the first instance we designed a feasibility pilot trial (VAginoscopy versus Standard Teloscope for office hysteroscopy trial; VAST) to inform the design, conduct and feasibility of a larger scale RCT. 4. Objectives

1. To estimate whether the vaginoscopic technique is potentially more successful compared to traditional approaches where success is defined as a completed diagnostic hysteroscopy with an acceptable level of patient reported pain without a vasovagal episode or post-operative uterine infection. 2. To test the hypothesis that the success of vaginoscopy differs according to parity, menopausal status, obesity and cervical surgery. 3. To test the hypothesis that in women undergoing an office hysteroscopy, a vaginoscopic technique is associated with on average at least 10% less pain (as measured by visual analogues scores) compared to traditional approaches. 4. To test the hypothesis that in women undergoing an office hysterosocpy, a vaginoscopic technique is associated with fewer vaso-vagal episodes compared to traditional approaches. 5. To test the hypothesis that in women undergoing an office hysteroscopy, there is no difference in the rates of failure to complete the procedure between vaginoscopy and traditional approaches. 6. To test the hypothesis that in women undergoing an office hysteroscopy, there is no difference in the incidence of post-operative uterine infection between vaginoscopy and traditional approaches. 7. To test the hypothesis that in women undergoing an office hysteroscopy, a vaginoscopic technique is associated with better patient acceptability. 5. References

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Cooper, N.A.M., Smith, P., Khan, K.S., and Clark, T.J. (2010). Vaginoscopic approach to outpatient hysteroscopy: a systematic review of the effect on pain. BJOG Int. J. Obstet. Gynaecol. 117, 532-539.

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Paschopoulos, M., Paraskevaidis, E., Stefanidis, K., Kofinas, G., and Lolis, D. (1997). Vaginoscopic approach to outpatient hysteroscopy. J. Am. Assoc. Gynecol. Laparosc. 4, 465-467.

Sagiv, R., Sadan, O., Boaz, M., Dishi, M., Schechter, E., and Golan, A. (2006). A new approach to office hysteroscopy compared with traditional hysteroscopy: a randomized controlled trial. Obstet. Gynecol. 108, 387-392.

Sharma, M., Taylor, A., di Spiezio Sardo, A., Buck, L., Mastrogamvrakis, G., Kosmas, I., Tsirkas, P., and Magos, A. (2005). Outpatient hysteroscopy: traditional versus the "no-touch" technique. BJOG Int. J. Obstet. Gynaecol. 112, 963-967.