The first aim is to study the learning curve of a student and a gynecologist for performing a translabial 3D ultrasound scan and of the capacity to read a scan and judge the integrity of the levator ani. Furthermore a comparison will be made between…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
prolaps en incontinentie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. How many 3D ultrasoundscans of the pelvic floor does a gynecologist with
experience in gynecological ultrasound need to perform to visualise all
essential referencepoints to reach an inter observer agreement with a weighted
kappa of 0.8 compared to an expert.
2. How many 3D ultrasoundscans of the pelvic floor does a student with no
ultrasound experience need to perform to visualise all essential
referencepoints to reach an inter observer agreement with a weighted kappa0.8.
compared to an expert.
3. How many recorded ultrasoundscans does a gynecologist with experience in
gynecological ultrasound need to read to learn to judge the integrity of the
levator ani to reach an inter observer agreement with an ICC of 0.6. compared
to an expert.
4. How many recorded ultrasoundscans does a student with ultrasound experience
need to read to learn to judge the integrity of the levator ani to reach an
inter observer agreement with an ICC of 0.6. compared to an expert.
Secondary outcome
5. What is the inter test agreement (weighted kappa) between a Voluson GE Kretz
and Toshiba ultrasoundmachine in visualising the reference points essential in
3D ultrasound of the pelvic floor.
6. What is the inter test agreement (ICC) between a Voluson GE Kretz and
Toshiba ultrasoundmachine in the judgement of the integrity of the levator
ani.
Background summary
Levatordefects occur in approximately 20-30% of deliveries. Levatordefects are
a risk factor for developing pelvic floor dysfunction and prolapse.
Levatordefects are associated with an increased risk for recurrence after
surgery. Levatordefects can be diagnosed by 3D/4D translabial ultrasound and by
MR imaging. The role of ultrasound in daily care for diagnosing levatordefects
in relation to the reference standard MRI has to be assessed. For this
assessment and for clinical practice we have to know whether it is necessary
that the gynecologists performs and reads the ultrasound scans or someone else
can learn to make thes scans and judge them.This study focuses on the learning
curve of 3D translabial 3D ultrasound of the pelvic floor to prepare the
implementation of pelvic floor ultrasound. All studies described in literature
are performed on the Voluson GE Kretz . We need to know whether the knowledge
of the software applications for optimizing the images on the Voluson
ultrasound machine can be extrapolated to other machines.
Study objective
The first aim is to study the learning curve of a student and a gynecologist
for performing a translabial 3D ultrasound scan and of the capacity to read a
scan and judge the integrity of the levator ani. Furthermore a comparison will
be made between two ultrasound machines to find out whether the knowledge of
the Voluson GE Kretz on translabial ultrasound of the pelvic floor can be
extrapolated to other machines.
Study design
multicentre prospective observational cohort study
Study burden and risks
Patients that join the study have to visit the hospital one time extra.
Ultrasonography of the levator ani has no risk for general health and no
radiation is used. The ultrasound exam will be performed by three different
docters. No questionnaires and no follow-up appointment are needed.
There is no benefit for the patient by joining the study.
The costs for travelling and parking will be compensated.
postbus 5800
6202 AZ Maastricht
NL
postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
women with symptoms of pelvic organ prolapse or incontinence.
Exclusion criteria
younger than 18
people who are not able to understand the information
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 | NL33468.068.10 |