Vaginoscopy Against Standard Treatment (VAST)

• Research type

  Research Study

• Full title

  Vaginoscopy Against Standard Treatment (VAST): a randomised controlled trial.

• IRAS ID

  133937

• Contact name

  Thomas Justin Clark

• Sponsor organisation

  NHS, Birmingham Womens Hospital

• Research 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’. In recent times the equipment used to perform hysteroscopy have become smaller such that it is routinely carried out without anaesthetic in an outpatient hospital or community clinic. 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. If this is shown to be the case, many patients will benefit immediately as vaginoscopy requires little training and requires no additional capital resources. Surveys have demonstrated that the trial is strongly supported by gynaecologists and patients.

• REC name

  West Midlands - Solihull Research Ethics Committee

• REC reference

  13/WM/0471

• Date of REC Opinion

  20 Jan 2014

• REC opinion

  Further Information Favourable Opinion