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

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.

Conditions

• Hysteroscopy Technique

Interventions

PROCEDURE

Vaginoscopy

Vaginoscopy, otherwise known as the 'no touch' technique, describes a technique where the hysteroscope is guided into the uterus without the need for potentially painful vaginal instrumentation i.e. passage of a vaginal speculum to separate the vaginal walls, cleansing of the cervix and sometimes application of traumatic forceps to the ectocervix in order to stabilise it.

PROCEDURE

Standard Hysteroscopy

Traditional hysteroscopy consists of introducing speculum and grasping of the cervix to provide counter traction to allow instrumentation of the uterus. Introducing a speculum also allows the cervix to be cleaned with sterilising fluid.

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Thomas J Clark, MD(hons) · Birmingham Women's NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2017-10-31

Completion

2017-10-31

Countries

• United Kingdom

Study Locations