Clinical trial NCT01972945: Vaginoscopy Against Standard Treatment (VAST): a Randomised Controlled Trial
Official title: Vaginoscopy Against Standard Treatment (VAST): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysteroscopy Technique
Keywords: vaginoscopy
hysteroscopy
office hysteroscopy
outpatient hysteroscopy
Lead sponsor: Birmingham Women's NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2013-10-31
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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

Almeida, Z.M.M.C. de, Pontes, R., and Costa, H. de L.F.F. (2008). \[Evaluation of pain in diagnostic hysteroscopy by vaginoscopy using normal saline at body temperature as distension medium: a randomized controlled trial\]. Rev. Bras.

Ginecol. E Obstetrícia Rev. Fed. Bras. Soc. Ginecol. E Obstetrícia 30, 25-30.

Busquets, M., and Lemus, M. (1993). \[Practicability of panoramic hysteroscopy with CO2. Clinical experience: 923 cases\]. Rev. Chil. Obstet. Ginecol. 58, 113-118.

Clark, T.J., and Gupta, J.K. (2005). Handbook of outpatient hysteroscopy: a complete guide to diagnosis and therapy (CRC Press).

Clark, T.J., Cooper, N.A., and Kremer, C. Best practice in outpatient hysteroscopy.

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.

Garbin, O., Kutnahorsky, R., Göllner, J.L., and Vayssiere, C. (2006). Vaginoscopic versus conventional approaches to outpatient diagnostic hysteroscopy: a two-centre randomized prospective study. Hum. Reprod. Oxf. Engl. 21, 2996-3000.

Guida, M., Di Spiezio Sardo, A., Acunzo, G., Sparice, S., Bramante, S., Piccoli, R., Bifulco, G., Cirillo, D., Pellicano, M., and Nappi, C. (2006). Vaginoscopic versus traditional office hysteroscopy: a randomized controlled study. Hum. Reprod. Oxf. Engl. 21, 3253-3257.

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.

Eligibility criteria: Inclusion Criteria:

* Aged 16years or over
* Referred for diagnostic of operative hysteroscopy in the outpatient setting
* Written informed consent obtained prior to the hysteroscopy

Exclusion Criteria:

* Need for hysteroscopic surgical intervention that requires cervical dilatation e.g. Novasure uterine ablation

Primary outcomes:
measure: Hysteroscopy success (composite primary outcome)
timeFrame: At the time of surgery (day 1) for all elements except for infection (day 14)
Secondary outcomes:
measure: Procedure Pain
timeFrame: At the time of surgery (day 1)
measure: Procedure failures
timeFrame: At the time of surgery (day 1)
measure: Infection rates
timeFrame: Two weeks post procedure (day 14)
measure: Vasovagal episodes
timeFrame: At the time of surgery (day 1)
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Womens Hospital
state: West Midlands
Study officials:
affiliation: Birmingham Women's NHS Foundation Trust
name: Thomas J Clark, MD(hons)
role: PRINCIPAL_INVESTIGATOR
References: