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Effectiveness of saline-infused sonography and hysteroscopy in the work-up for postmenopausal bleeding

Effectiveness of saline-infused sonography and hysteroscopy in the work-up for postmenopausal bleeding - POMPOEN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32122
Enrollment
200
Registered
2008-12-01
Start date
2008-11-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

bleeding after menopause postmenopausal bleeding

Interventions

Patients will be randomised for a subsequent diagnostic work-up with SIS and hysteroscopy or no further diagnostic work-up. In case the patient is allocated to no diagnostic work-up, she will be sen

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with postmenopausal bleeding and an endometrial thickness of more than 4 mm measured by transvaginal sonography

Exclusion criteria

Exclusion criteria: Patients in whom cervical cytology or endometrial biopsy shows malignancy and patients in whom endometrial biopsy failed of cannot rule out malignancy

Design outcomes

Primary

MeasureTime frame
Recurrence of postmenopausal bleeding.

Secondary

MeasureTime frame
What is the added diagnostic informativeness of SIS in the diagnosis of endometrial polyps using hysteroscopy as the reference standard? What are the costs of TVS, saline infused sonography, hysteroscopy, as well as the costs of recurrent bleeding?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)