The specimen contains less evaluable endometrium after SIS than before SIS.
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Quality assessment of aspiraton specimen by pathologist.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The specimen contains less evaluable endometrium after SIS than before SIS.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
VU University Medical Center
De Boelelaan 1117
A.J.M. Bij de Vaate
Amsterdam 1081 HV
The Netherlands
+31 20 4443613
m.bijdevaate@vumc.nl
Wetenschappers
VU University Medical Center
De Boelelaan 1117
A.J.M. Bij de Vaate
Amsterdam 1081 HV
The Netherlands
+31 20 4443613
m.bijdevaate@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patiens with abnormal uterine bleeding.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. PID;
2. Cervical cancer.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL863 |
NTR-old | NTR877 |
Ander register | : N/A |
ISRCTN | ISRCTN43875039 |