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

NCT01972945 | Completed

• 1 other identifier: VAST
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysteroscopy Technique

Keywords

vaginoscopy; hysteroscopy; office hysteroscopy; outpatient hysteroscopy

Outcome Measures

Primary Outcomes (1)

• Hysteroscopy success (composite primary outcome)

  The primary clinical outcome is a composite outcome of a completed hysteroscopy with an acceptable level of patient reported pain without a vasovagal episode or post-operative uterine infection. A composite outcome has been chosen as it was felt that all of these factors are important to classify a hysteroscopy as successful. See individual elements in secondary outcomes for a description of how they will be measured

  At the time of surgery (day 1) for all elements except for infection (day 14)

Secondary Outcomes (4)

• Procedure Pain

  At the time of surgery (day 1)

• Procedure failures

  At the time of surgery (day 1)

• Infection rates

  Two weeks post procedure (day 14)

• Vasovagal episodes

  At the time of surgery (day 1)

Study Arms (2)

Vaginoscopy

EXPERIMENTAL

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: Vaginoscopy

Standard Hysteroscopy

ACTIVE COMPARATOR

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.

Procedure: Standard Hysteroscopy

Interventions

Vaginoscopy PROCEDURE

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.

Also known as: no touch technique

Vaginoscopy

Standard Hysteroscopy PROCEDURE

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.

Standard Hysteroscopy

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust: lead

Study Sites (1)

Birmingham Womens Hospital

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

Study Officials

• Thomas J Clark, MD(hons)

  Birmingham Women's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetrician and Gynaecologist

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: March 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

GB (1)