The primary objective is to investigate the quality (whether assessable by a pathologist or not) of the endometrial sample obtained by aspiration when performed directly before or after the SIS in postmenopausal women. Secondary objectives are to…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Menopause related conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is to investigate the quality of the endometrial samples
obtained before or after SIS to determine whether the order of investigations
is of any influence to the percentages of sufficient endometrial samples
(assessable).
Secondary outcome
Secondary outcomes are to determine whether the order of investigations is of
any influence to the reliability of the SIS images, to determine which
investigation is experienced as the most painful and to determine in which
group one of the procedures has a high failure risk (e.g. stenosis).
Background summary
Postmenopausal bleeding is a very common complaint and can relate to several
benign or malignant conditions. One of the options to perform a complete and
minimal invasive work-up for women with postmenopausal bleeding is to combine
saline infusion sonography (SIS )and office endometrium sampling by aspiration
in one session after prior transvaginal ultrasonography (TVU) shows a thickened
endometrium(*4mm). However the effects of the SIS to the quality of the sample
and the effects of sampling to the quality of the SIS when combined are unknown
in postmenopausal women.
Study objective
The primary objective is to investigate the quality (whether assessable by a
pathologist or not) of the endometrial sample obtained by aspiration when
performed directly before or after the SIS in postmenopausal women. Secondary
objectives are to investigate reliability of sonograpic images of the SIS when
performed directly before or after the endometrial sampling, to investigate the
incidence and intensity of the pain and to investigate the incidence with
reasons of failed procedures.
Study design
Randomized controlled trial in two teaching hospitals in the Netherlands.
Intervention
We will perform a randomised controlled trial comparing two diagnostic
work-ups. One group will first receive SISand subsequent office endometrial
sampling, and the other group will first receive office endometrial sampling
and subsequent SIS, both in one session. For both groups we will use a
SIS-catheter to perform the SIS and a Pipelle device to perform endometrial
sampling.
Study burden and risks
Both of the procedures are part of the standard diagnostic work-up for
postmenopausal bleeding in an outpatient setting, in the current guidelines
there is no consensus whether SIS or sampling should be perform first. Both
investigations are considered safe and proved to be effective to detect
abnormalities in women with postmenopausal bleeding. As only the order of
investigations will be investigated, there will be no disadvantages for the
subjects. Hypothetically the order of investigations can affect the quality of
the sample. Subjects with an inconclusive sample and/or SIS will receive
(outpatient) hysteroscopy to avoid missing any diagnosis of cancer. This is in
accordance with the present guidelines.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
Women with postmenopausal bleeding and an endometrial thickness of 4mm>.
Exclusion criteria
Women receiving Hormone Replacement Therapy
Women receiving Tamoxifen
Women with cervical cancer.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN43875039 |
| CCMO | NL56373.015.16 |
| OMON | NL-OMON22688 |