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van CCT (UK)


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van CCT (UK)


RCT to investigate the quality of the of endometrial sample obtained by aspiration when performed before or after the Saline Infusion Sonography (SIS) in postmenopausal women


- candidate number23978
- NTR NumberNTR5690
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2016
- Secondary IDsNL56373.015.16  ESPRESSO
- Public TitleRCT to investigate the quality of the of endometrial sample obtained by aspiration when performed before or after the Saline Infusion Sonography (SIS) in postmenopausal women
- Scientific TitleEndometrial SamPling befoRe or aftEr Saline infusion SOnography (ESPRESSO Trial)
- ACRONYMESPRESSO
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedPostmenopausal bleeding, Endometrial hyperplasia
- Inclusion criteriaWomen with postmenopausal bleeding and an endometrial thickness of 4mm or more.
- Exclusion criteriaWomen receiving Hormone Replacement Therapy.
Women receiving Tamoxifen
Women with cervical cancer.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-apr-2016
- planned closingdate1-apr-2017
- Target number of participants232
- InterventionsWe 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.
- Primary outcomeThe 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).
- Secondary outcome Secondary outcomes are to determine whether the order of investigations is of any influence to the reliability of the SIS images and to determine which investigation is experienced as the most painful. Furthermore we will evaluate the failed procedures and specific pathological analysis will be performed by a pathologist specialized in gynaeco-pathology.
- TimepointsThe 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.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Albertine Vroom
- CONTACT for SCIENTIFIC QUERIESDr. Marlies Bongers
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD16-feb-2016 - 22-mei-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl