|- candidate number||23978|
|- NTR Number||NTR5690|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-feb-2016|
|- Secondary IDs||NL56373.015.16 ESPRESSO|
|- Public Title||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
|- Scientific Title||Endometrial SamPling befoRe or aftEr Saline infusion SOnography (ESPRESSO Trial)
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Postmenopausal bleeding, Endometrial hyperplasia|
|- Inclusion criteria||Women with postmenopausal bleeding and an endometrial thickness of 4mm or more.
|- Exclusion criteria||Women receiving Hormone Replacement Therapy. |
Women receiving Tamoxifen
Women with cervical cancer.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||11-apr-2016|
|- planned closingdate||1-apr-2017|
|- Target number of participants||232|
|- Interventions||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.
|- Primary outcome||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).
|- 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.
|- Timepoints||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.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Albertine Vroom|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Marlies Bongers|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|Maxima Medical Center|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||16-feb-2016 - 22-mei-2016|