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).
- Conditions
- English:- Hysteroscopy- Versascope- Continuous Real time Pain Measurement- Pain- Visual Analogue Scale (VAS)/Verbal Rating Score (VRS)Dutch:- Hysteroscopie- Versascoop- Pijn
- Registration Number
- NL-OMON27942
- Lead Sponsor
- VU medical centre
- Brief Summary
Publication follows: Cohortstudy and RCT (GISPAIN)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 98
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary 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 Outcome Measures
Name Time Method Secondary endpoints will be:<br /><br>- The total operation time<br /><br>- The pain during passage of the cervix measured as the Peak Pain Score (PPS) and the Average Pain per Second (APS)<br /><br>- The pain during passage of a 5 French instrument through the working chanal of the scoop measured as AUC, APS and PPS<br /><br>- Total experienced pain during the procedure as measured as AUC and APS<br /><br>- The postoperative pain measured directly after the procedure, measured by Visual analogue Scale / Verbal Rating Score (VRS, 0-10)<br /><br>- The use of analgetics<br /><br>- The necessity for cervical dilatation<br /><br>- The easiness of use of the scopes (5 point scale)<br /><br>- Image quality (5 point scale)<br /><br>- Anxiety (10 point scale)