|- candidate number||6778|
|- NTR Number||NTR2130|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-dec-2009|
|- Secondary IDs||08/177 MEC AMC|
|- Public Title||Effectiveness of saline-infused sonography and hysteroscopy in the work-up for postmenopausal bleeding.|
|- Scientific Title||Effectiveness of saline-infused sonography and hysteroscopy in the work-up for postmenopausal bleeding.|
|- hypothesis||Uterine cavity evaluation and subsequent resection of endometrial polyps in women with postmenopausal bleeding and endometrial thickness of more than 4 mm will lead to less recurrent bleeding compared to women in whom such is not performed.|
|- Healt Condition(s) or Problem(s) studied||Endometrial polyps, Postmenopausal bleeding|
|- Inclusion criteria||Women with postmenopausal bleeding and an endometrial thickness of more than 4 mm in whom a malignancy is ruled out by office endometrial sampling.|
|- Exclusion criteria||1. Women with postmenopausal bleeding during tamoxifen or arimidex treatment;|
2. Women with an endometrial sample containing insufficient material for a reliable diagnosis;
3. Women with suspected malignancy after endometrial sampling or cervical cytology.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2010|
|- planned closingdate||1-jan-2012|
|- Target number of participants||200|
|- Interventions||Eligible patients will be randomly allocated to undergo saline infused sonography (SIS) and outpatient hysteroscopy. All patients will undergo SIS and hysteroscopy independent of the findings during SIS. In case a polyp is seen at hysteroscopy, immediate resection will be performed.|
The control group will receive no further diagnostic work-up.
|- Primary outcome||The recurrence of postmenopausal bleeding.|
|- Secondary outcome||Secondary outcomes are:|
1. What is the added informativeness of SIS in the diagnosis of endometrial polyps using hysteroscopy as a reference standard?
2. What are the costs of transvaginal sonography, SIS and hysteroscopy as well as the costs of recurrent postmenopausal bleeding?
|- Timepoints||An interim analysis is not planned.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| M.C. Breijer|
|- CONTACT for SCIENTIFIC QUERIES||Prof. B.W.J. Mol|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Brief summary||Introduction:|
Postmenopausal bleeding occurs in approximately 15,000 women per year, and may signal serious underlying medical problems. The Dutch guideline on the work-up for postmenopausal bleeding emphasizes diagnosing malignant pathology of the endometrium. Transvaginal sonography is used to measure endometrial thickness, if the endometrial thickness measures more than 4 mm, endometrium aspiration (using a Pipelle) is advocated to rule out or diagnose endometrial carcinoma. When malignancy has been ruled out, it is uncertain whether the work-up should be continued with SIS and/or hysteroscopy (and subsequent polypectomy when an abnormality is detected), if at all. The present proposal will study the effects of these strategies. The proposal will consider medical effectiveness.
SIS and hysteroscopy in the work-up for postmenopausal bleeding will be studied. Medical effectiveness in terms of treatment of the postmenopausal bleeding will be evaluated. To assess which women need saline-infused sonography and/or hysteroscopy, if at all, we will answer the following questions:
What are the effects of the following strategies:
1. No further testing after carcinoma has been ruled out;
2. SIS for all patients, and hysteroscopy after abnormal SIS;
3. Immediate hysteroscopy for all patients;
4. Targeted selection of patients at increased risk for polyps.
Patients will be randomised for a subsequent diagnostic work-up with SIS and hysteroscopy or no further diagnostic work-up.
Primary Study parameter:
Recurrence of postmenopausal bleeding.
|- Main changes (audit trail)|
|- RECORD||3-dec-2009 - 14-jul-2017|