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Randomized controlled trial of treatment of endometrial polyps in case of postmenopausal bleeding.

Randomized controlled trial of treatment of endometrial polyps in case of postmenopausal bleeding.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20104
Enrollment
60
Registered
2005-09-09
Start date
2005-09-01
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

Women with postmenopausal bleeding and endometrial polyp(s).

Interventions

Resection will take place in the same session in which the polyp is diagnosed. Resection is performed following standard procedures used in the residential hospital. Resection of endometrial polyp i

Sponsors

Sponsor is St. Antonius ziekenhuis Postbus 2500 3430 EM Nieuwegein tel: 030-6092086 fax: 030-6051270 Koekoekslaan 1 Nieuwegein Telefoon/Fax Telefoon: 030-609 9111 Fax: 030-609 2999
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women with postmenopausal bleeding and endometrial thickness of more than 4 mm in whom an endometrial polyp is diagnosed during hysteroscopy.

Exclusion criteria

Exclusion criteria: Women with postmenopausal bleeding on tamoxifen treatment. Women with postmenopausal bleeding with (supsicion of) malignancy during hysteroscopy.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the recurrence of postmenopausal bleeding.

Secondary

MeasureTime frame
Quality of life will be assessed using several standard self-administered psychometric measures with established reliability and validity. We will use the Short Form 36 (SF36), the State Trait Anxiety Score (STAI). Moreover, patient satisfaction will be assessed using a VAS score.

Contacts

Public ContactA. Timmermans

Markstraat 42

anne_timmermans@hotmail.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)