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

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ClinicalTrials.gov Identifier: NCT01972945
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Justin Clark, Birmingham Women's NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Hysteroscopy Technique Procedure: Vaginoscopy Procedure: Standard Hysteroscopy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Vaginoscopy Against Standard Treatment (VAST): a Randomised Controlled Trial
Actual Study Start Date : March 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: 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: 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.
Other Name: no touch technique

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Hysteroscopy success (composite primary outcome) [ Time Frame: At the time of surgery (day 1) for all elements except for infection (day 14) ]
    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


Secondary Outcome Measures :
  1. Procedure Pain [ Time Frame: At the time of surgery (day 1) ]
    The main limitation of outpatient interventions is the amount of pain generated. Visual analogue scales (VAS) originally devised as measured of well-being have been successfully adapted to measure pain. This technique involves use of 10cm line of a piece of paper representing a continuum of the patients' opinion of the degree of pain. It is explained to the patient that the one extreme of the line represent "no pain at all" while the other represents "as much pain as she can possibly imagine". The subject rates the degree of pain by placing a mark on the line and scale values are obtained by measuring the distance from zero to that mark. The reliability of visual analogue scales in the assessment of pain has established as reproducible and accurate. A baseline pain questionnaire will be administered before the procedure and a further pain assessment will be made immediately after treatment.

  2. Procedure failures [ Time Frame: At the time of surgery (day 1) ]
    Part of the primary clinical outcome is to test whether the vaginoscopic technique reduces the number of procedure failures. Unfortunately, it is occasionally necessary to abandon outpatient hysteroscopic procedure normally because of pain or anxiety. The clinician will collect this data on the treatment form.

  3. Infection rates [ Time Frame: Two weeks post procedure (day 14) ]

    The patient will be contacted two weeks after the procedure. An infection will be defined as any of the following in the two-week period after the procedure:

    1. If the patient has received antibiotics for a urinary tract infection
    2. If the patient has received antibiotics for vaginal discharge
    3. If the patient reports 2 out of the following 3 symptoms: offensive vaginal discharge, pelvic pain and pyrexia.

  4. Vasovagal episodes [ Time Frame: At the time of surgery (day 1) ]
    Another part of the primary outcome is assessing whether vaginoscopy reduces the number of vasovagal episodes. Vaso-vagal reactions will be defined clinically as patient is unable to leave operating couch within 5minutes of cessation of procedure due to feeling faint or dizzy or nauseous. The clinical will collect this data on the treatment form.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972945


Locations
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United Kingdom
Birmingham Womens Hospital
Birmingham, West Midlands, United Kingdom, B15 2TT
Sponsors and Collaborators
Birmingham Women's NHS Foundation Trust
Investigators
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Principal Investigator: Thomas J Clark, MD(hons) Birmingham Women's NHS Foundation Trust

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Responsible Party: Thomas Justin Clark, Consultant Obstetrician and Gynaecologist, Birmingham Women's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01972945     History of Changes
Other Study ID Numbers: VAST
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Keywords provided by Thomas Justin Clark, Birmingham Women's NHS Foundation Trust:
vaginoscopy
hysteroscopy
office hysteroscopy
outpatient hysteroscopy