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Effectiveness of saline-infused sonography and hysteroscopy in the work-up for postmenopausal bleeding.


- candidate number6778
- NTR NumberNTR2130
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-dec-2009
- Secondary IDs08/177 MEC AMC
- Public TitleEffectiveness of saline-infused sonography and hysteroscopy in the work-up for postmenopausal bleeding.
- Scientific TitleEffectiveness of saline-infused sonography and hysteroscopy in the work-up for postmenopausal bleeding.
- ACRONYMPOMPOEN
- hypothesisUterine 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) studiedEndometrial polyps, Postmenopausal bleeding
- Inclusion criteriaWomen with postmenopausal bleeding and an endometrial thickness of more than 4 mm in whom a malignancy is ruled out by office endometrial sampling.
- Exclusion criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2012
- Target number of participants200
- InterventionsEligible 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 outcomeThe recurrence of postmenopausal bleeding.
- Secondary outcomeSecondary 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?
- TimepointsAn interim analysis is not planned.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES M.C. Breijer
- CONTACT for SCIENTIFIC QUERIESProf. B.W.J. Mol
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryIntroduction:
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.

Objective:
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.

Intervention:
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)
- RECORD3-dec-2009 - 14-jul-2017


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