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ISRCTN
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ISRCTN78400671
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ClinicalTrials.gov identifier
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Public title
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Optimum intrauterine filling pressures needed to perform outpatient diagnostic hysteroscopy
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Scientific title
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Optimum intrauterine filling pressures needed to perform outpatient diagnostic hysteroscopy: a double-blind randomised trial
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Acronym
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N/A
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Serial number at source
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06/0112
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Study hypothesis
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The filling pressures used to perform outpatient diagnostic hysteroscopy can be reduced without compromising the visualisation of uterine cavity and this may reduce the pain experienced by the woman
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Lay summary
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Lay summary under review
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Ethics approval
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The Joint UCL/UCLH Committes on the Ethics of Human Research, 28 September 2006, ref: 06/Q0502/69
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Study design
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Double blind randomised trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Hysteroscopy
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Participants - inclusion criteria
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1. Women who are referred for an outpatient hysteroscopy procedure at the Univesity College London Hospitals
2. Those who give informed consent to participate in the trial
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Participants - exclusion criteria
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1. Women who are unable to communicate in English
2. Those whoe are not suitable for an outpatient hysteroscopy (i.e active pelvic infection, possibility of pregnancy, unusually anxious women)
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Anticipated start date
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01/03/2007
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Anticipated end date
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31/03/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information leaflet
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Target number of participants
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230 women
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Interventions
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Women who are due to undergo an outpatient hysteroscopy procedure will be recruited after obtaining informed consent. They will be allocated to one of the three pressure groups (100mmHg, 70mmHg or 40mmHg) using computer generated random numbers sealed in an opaque envelope which is opened by the attending nurse or healthcare assistant who sets up the pressure of distension medium. The woman and the operator will be blinded to the allocated pressure. The hysteroscopy procedure will be performed by an experienced operator who will judge whether the uterine distension is adequate or inadequate. At this point the women will be asked to report her pain score between 0 to 10, using a Visual Analogue Scale. If the visualisation of the uterine cavity is inadequate, the operator will then ask the nurse/healthcare assistant to establish the pressure to 100 mmHg, which is the standard distension pressure used in the department to complete the procedure. Any additional necessary procedures such as biopsy, polyp or fibroid removal will be carried out after the assessment of the operator and the woman.
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Primary outcome measure(s)
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Adequate visualisation of the uterine cavity assessed at the same point when the operator judges whether the visualisation is adequate or inadequate
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Secondary outcome measure(s)
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Visual Analogue Score (VAS) pain score assessed at the same point when the operator judges whether the visualisation is adequate or inadequate
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Sources of funding
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University College London Hospitals NHS Foundation Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Ertan
Saridogan
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Address
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Women's Health Division
University College London Hospitals
250 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2PG
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Country
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United Kingdom
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Email
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ertan.saridogan@uclh.nhs.uk
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Sponsor
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University College London Hospitals NHS Foundation Trust (UK)
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Address
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250 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2PG
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Country
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United Kingdom
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Tel
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+44 (0)20 3456 7890
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Email
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ertan.saridogan@uclh.nhs.uk
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Sponsor website:
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http://www.uclh.org/
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Date applied
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02/12/2011
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Last edited
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19/12/2011
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Date ISRCTN assigned
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19/12/2011
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