SIS and hysteroscopy in the work-up for postmenopausal bleeding will be studied. Cost en medical effectiveness in terms of treatment of the postmenopausal bleeding will be evaluated. To assess which women need saline-infused sonography and/or…
ID
Source
Brief title
Condition
- Menopause related conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recurrence of postmenopausal bleeding.
Secondary outcome
What is the added diagnostic informativeness of SIS in the diagnosis of
endometrial polyps using hysteroscopy as the reference standard?
What are the costs of TVS, saline infused sonography, hysteroscopy, as well as
the costs of recurrent bleeding?
Background summary
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 emphasises 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 costs
and effects of these strategies. The proposal will consider medical
effectiveness and costs.
Study objective
SIS and hysteroscopy in the work-up for postmenopausal bleeding will be
studied. Cost en 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 cost and 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
Study design
Multicenter randomised trial.
Intervention
Patients will be randomised for a subsequent diagnostic work-up with SIS and
hysteroscopy or no further diagnostic work-up. In case the patient is allocated
to no diagnostic work-up, she will be send home without further diagnostic
tests. She will be instructed to contact the gynaecologists in case of
recurrence of vaginal bleeding.
Study burden and risks
In women with postmenopausal bleeding it is unclear whether the work up after
excluding malignancy should be continued with SIS and/or hysteroscopy, if at
all. The potential benefit of SIS and hysteroscopy could be the detection of
intracavitary abnormalities (i.e. polyps) and subsequent resection and thereby
decreasing the recurrence of postmenopausal bleeding.
Potential risks associated with SIS and hysteroscopy are uterus perforation,
infection and bleeding
Meibergdreef 9
1105AZ Amsterdam
Nederland
Meibergdreef 9
1105AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients with postmenopausal bleeding and an endometrial thickness of more than 4 mm measured by transvaginal sonography
Exclusion criteria
Patients in whom cervical cytology or endometrial biopsy shows malignancy and patients in whom endometrial biopsy failed of cannot rule out malignancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23522.018.08 |