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van CCT (UK)

van CCT (UK)

Office hysteroscopy using the Versascope versus a 5.5 mm scope, comparison of pain (Poliklinische hysteroscopie gebruikmakende van de Versascoop versus de 5.5 mm scoop, vergelijking van pijn).

- candidate number19060
- NTR NumberNTR4700
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jul-2014
- Secondary IDsABR: 50216 
- Public TitleOffice hysteroscopy using the Versascope versus a 5.5 mm scope, comparison of pain (Poliklinische hysteroscopie gebruikmakende van de Versascoop versus de 5.5 mm scoop, vergelijking van pijn).
- Scientific TitleOffice hysteroscopy using the Versascope versus a 5.5 mm scope, comparison of pain; A single blind randomized controlled trial
- hypothesisThe Versascope (3.5-5.3mm diameter) induces less pain than a conventional hysteroscope (5.5mm diameter) during a hysteroscopic procedure in an office setting.
- Healt Condition(s) or Problem(s) studiedHysteroscopy, Pain
- Inclusion criteria- Woman with abnormal uterine bleeding or subfertility problems and suspected for having an intrauterine abnormality
- Age 20-80 yr
- Exclusion criteria- Pregnancy or premenopausal women in the luteal phase without use of contraception
- Pelvic Inflammatory Disease (PID)
- Risk of malignancy
- Contraindication for the use of NSAIDS
- Inability to understand Dutch or English
- Inability to use the pain score meter in the right manner
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate1-nov-2015
- Target number of participants98
- InterventionsIntervention group: The use of the Versascope. Control group: The use of the 5,5 mm scope.
- Primary outcomePrimary endpoint is the Area Under the Curve (AUC) of continuous registered pain score (VAS, measured by the Continuous pain Score Meter) during the passage of the hysteroscope through the cervical canal.
- Secondary outcomeSecondary endpoints will be:
- The total operation time
- The pain during passage of the cervix measured as the Peak Pain Score (PPS) and the Average Pain per Second (APS)
- The pain during passage of a 5 French instrument through the working chanal of the scoop measured as AUC, APS and PPS
- Total experienced pain during the procedure as measured as AUC and APS
- The postoperative pain measured directly after the procedure, measured by Visual analogue Scale / Verbal Rating Score (VRS, 0-10)
- The use of analgetics
- The necessity for cervical dilatation
- The easiness of use of the scopes (5 point scale)
- Image quality (5 point scale)
- Anxiety (10 point scale)
- TimepointsSee secondary outcomes
- Trial web siteCCMO
- statusplanned
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Onze Lieve Vrouwe Gasthuis (OLVG)
- PublicationsPublication follows: Cohortstudy and RCT (GISPAIN)
- Brief summaryThe Versascoop is a recentely developped hysteroscopic instrument with a number of innovations that are likely to improve the patients tolerance for hystoroscopy in an office setting. Conventional office hysteroscopes have a diameter of 5,5 mm, including an in- and outflow channel for distention fluid and a 5 French working channel for therapeutic interventions. The Versascope has a diameter of 3,5 mm, with an in- and outflow channel, and a expandable working channel due to a flexible outer sheath, in which instruments can be used up to 7 French, enlarging the outer diameter to 5,3 mm. Despite its small diameter, the 3,5 mm scope provides sharp images and good visualisation of the uterine cavity, comparable with the conventional office hysteroscopes.
The smaller diameter of the Versascope suggests that the hysteroscopic procedure should be less painfull compared to the conventional 5,5 mm hysteroscope because dilatation of the cevical canal is a well known pain initiating intervention in women. However, comparative studies have not been published yet. To answer our hypothesis, except reporting the VAS/VRS, we will use a new instrument in measuring the pain; The Continuous Pain Score Meter (CPSM) or Dolorimeter.
- Main changes (audit trail)
- RECORD21-jul-2014 - 17-aug-2014

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