|- candidate number||2421|
|- NTR Number||NTR877|
|- Date ISRCTN created||27-jun-2007|
|- date ISRCTN requested||11-jun-2007|
|- Date Registered NTR||23-jan-2007|
|- Secondary IDs||N/A |
|- Public Title||Endometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding; effect on specimen quality.|
|- Scientific Title||Endometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding; effect on specimen quality.|
|- ACRONYM||Endometrial aspiration specimen quality after SIS|
|- hypothesis||The specimen contains less evaluable endometrium after SIS than before SIS.|
|- Healt Condition(s) or Problem(s) studied||Abnormal uterine bleeding, Saline infusion sonography (SIS) , Endometrial aspiration, Endometrial biopsy|
|- Inclusion criteria||Patiens with abnormal uterine bleeding.|
|- Exclusion criteria||1. PID; |
2. Cervical cancer.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2006|
|- planned closingdate||1-jul-2007|
|- Target number of participants||120|
|- Interventions||Saline 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 outcome||Quality assessment of aspiraton specimen by pathologist.|
|- Secondary outcome||Reliability of video SIS-images.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Mw.MD A.J.M. Bij de Vaate|
|- CONTACT for SCIENTIFIC QUERIES||Professor H.A.M. Brölmann|
|- Sponsor/Initiator ||VU University Medical Center, Department of Obstetrics and Gynaecology|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, Department of Obstetrics and Gynaecology|
|- Brief summary||Abnormal 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)|
|- RECORD||23-jan-2007 - 2-dec-2009|