Gel instillation sonohysterography (GIS) using Endosgel versus ExEmgel, comparison of pain and image quality

Gel instillation sonohysterography (GIS) using Endosgel versus ExEmgel, comparison of pain and image quality - GISPAIN

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38342

Enrollment

Registered

2012-03-07

Start date

2012-09-11

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

intra-uterine abnormalities polyp submucous fibroid

Interventions

Intervention group: The use of ExEmgel. Control group: The use of Endosgel. Both gels are used in daily practice (in the VUmc) during GIS.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - woman with abnormal uterine bleeding or infertility 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 - Known allergy for chloorhexidine - Inability to understand Dutch or English

Design outcomes

Secondary

Measure	Time frame
Other outcome parameters are pain score (AUC using continuous pain registration) of the entire procedure and of specific parts of the procedure, subjective reported VAS score and image quality. Various prognostic factors will be registered.	—

Primary

Measure	Time frame
Primary endpoint is AUC of continuous registered pain score (continuous VAS) during gel installation and following sonography.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)