In this randomised study we will investigate the quality of the endometrial sample obtained by office endometrial sampling when performed before or after the SIS in postmenopausal women. Hypothetically the quality of the sample can be affected by…
ID
Bron
Verkorte titel
Aandoening
Postmenopausal bleeding and a thickened endometrium
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main endpoint is to investigate the quality of the endometrial samples obtained before or after SIS to determine whether the order of investigations is of any influence to the percentages of sufficient endometrial samples (assessable).
Doel van het onderzoek
In this randomised study we will investigate the quality of the endometrial sample obtained by office endometrial sampling when performed before or after the SIS in postmenopausal women. Hypothetically the quality of the sample can be affected by fluid, when performed after the SIS.
Onderzoeksopzet
The endometrial sample and the SIS will be performed in a outpatient visit. The quality (sufficient for diagnosis) will be determined by a blinded pathologist. The gynaecologist (in training) will evaluate and save the SIS images for a second evaluation.
To evaluate the pain, the gynaecologist(in training) will record VAS scores, during and in between the investigations.
Specific pathological analysis and the second (blinded) evaluation of the SIS images will performed in another session.
Onderzoeksproduct en/of interventie
We will perform a randomised controlled trial comparing two diagnostic work-ups. One group will first receive SIS and subsequent office endometrial sampling, and the other group will first receive office endometrial sampling and subsequent SIS, both in one session. For both groups we will use a SIS-catheter to perform the SIS and a Pipelle device to perform endometrial sampling.
Publiek
Albertine Vroom
Veldhoven
The Netherlands
+31612339503
a.vroom@student.maastrichtuniversity.nl
Wetenschappelijk
Albertine Vroom
Veldhoven
The Netherlands
+31612339503
a.vroom@student.maastrichtuniversity.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Women with postmenopausal bleeding and an endometrial thickness of 4mm or more.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Women receiving Hormone Replacement Therapy.
Women receiving Tamoxifen
Women with cervical cancer.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL5568 |
NTR-old | NTR5690 |
CCMO | NL56373.015.16 |
OMON | NL-OMON43383 |