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).

Office hysteroscopy using the Versascope versus a 5.5 mm scope, comparison of pain; A single blind randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27942

Enrollment

Registered

2014-07-21

Start date

2014-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

English: - Hysteroscopy - Versascope - Continuous Real time Pain Measurement - Pain - Visual Analogue Scale (VAS)/Verbal Rating Score (VRS) Dutch: - Hysteroscopie - Versascoop - Pijn

Interventions

Intervention group: The use of the Versascope. Control group: The use of the 5,5 mm scope.

Eligibility

Inclusion criteria

Inclusion criteria: - Woman with abnormal uterine bleeding or subfertility problems and suspected for having an intrauterine abnormality - Age 20-80 yr

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary 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)	—

Measure

Time frame

Secondary 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)

—

Contacts

Public ContactM.D. Louwerse

m.louwerse@vumc.nl020-4444444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)