Hysteroscopy Technique Clinical Trial
Official title:
Vaginoscopy Against Standard Treatment (VAST): a Randomised Controlled Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06394752 -
UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY. This Study Will Compare the Intrauterine Pathology Detection Rate Between Standard of Care Hydrosonography, and a New Visual Saline Infusion Device Providing Direct Visualization of the Uterus.
|
N/A |