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Endometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding; effect on specimen quality.


- candidate number2421
- NTR NumberNTR877
- ISRCTNISRCTN43875039
- Date ISRCTN created27-jun-2007
- date ISRCTN requested11-jun-2007
- Date Registered NTR23-jan-2007
- Secondary IDsN/A 
- Public TitleEndometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding; effect on specimen quality.
- Scientific TitleEndometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding; effect on specimen quality.
- ACRONYMEndometrial aspiration specimen quality after SIS
- hypothesisThe specimen contains less evaluable endometrium after SIS than before SIS.
- Healt Condition(s) or Problem(s) studiedAbnormal uterine bleeding, Saline infusion sonography (SIS) , Endometrial aspiration, Endometrial biopsy
- Inclusion criteriaPatiens with abnormal uterine bleeding.
- Exclusion criteria1. PID;
2. Cervical cancer.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2006
- planned closingdate1-jul-2007
- Target number of participants120
- InterventionsSaline Infusion Sonography (SIS) and endometrial aspiration are performed with the same catheter in one session. Patients are either allocated to aspiration and subsequent SIS, or to the reverse order.
- Primary outcomeQuality assessment of aspiraton specimen by pathologist.
- Secondary outcomeReliability of video SIS-images.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMw.MD A.J.M. Bij de Vaate
- CONTACT for SCIENTIFIC QUERIESProfessor H.A.M. Brölmann
- Sponsor/Initiator VU University Medical Center, Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Department of Obstetrics and Gynaecology
- PublicationsN/A
- Brief summaryAbnormal uterine bleeding needs careful evaluation to exclude uterine pathology, particularly endometrial cancer. The combination of Saline Infusion Sonography (SIS) and endometrial aspiration is a reliable tool for evaluating abnormal uterine bleeding. SIS enables visualization of the endometrial surface and measurement of the thickness of the endometrium. Endometrial aspiration has been well established as a safe and accurate technique in diagnosing endometrial cancer. Especially in case of increased endometrium thickness, endometrial biopsy is indicated. Women with abnormal uterine bleeding often need multiple hospital visits. One of the advantages of combining SIS and endometrial aspiration is that both examinations can be performed with the same catheter in one session. Generally, first SIS is performed and subsequently aspiration. However, the quality of the endometrial sample might be affected by the fluid used to distend the uterine cavity. On the other hand, aspirating first may cause artefacts during SIS as parts of the endometrium may be detached from their basic layer. In this study the order of investigations on the quality of the endometrium sample is investigated. Patients with abnormal uterine bleeding are randomly allocated either to aspiration and subsequent SIS, or to the reverse order. All samples are sent to the same pathologist who will evaluate the quality of the specimen.
- Main changes (audit trail)
- RECORD23-jan-2007 - 2-dec-2009


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