1. To investigate the intra- and inter-observer agreement in the assessment of vaginal capillary density using SDF imaging. 2. To investigate whether between patients with and without pelvic organ prolapse (POP) and in the compartment with and…
ID
Source
Brief title
Condition
- Vulvovaginal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The intra- and inter-observer agreement of vaginal SDF imaging.
2. Differences in measurements of microcirculatory parameters between patients
with and without POP and between the compartment with and without POP within a
POP patient.
3. The best time interval to measure microcirculatory parameters after vaginal
prolapse surgery with a first assessment of the effects of prolapse surgery on
microcirculatory parameters.
Secondary outcome
nvt
Background summary
Vaginal prolapse surgery intends to correct pelvic floor dysfunction by
normalizing the anatomy of the vagina and its surrounding pelvic organs.
However, during surgery damage occurs to the vascularization of the vagina.
Whether this damage is reversible or not has never been studied. Neither is
known what the effect of prolapse itself is on the vascularisation of the
vagina.
Improved understanding of the effects of vaginal prolapse and prolapse surgery
on vaginal vascularisation may ultimately improve patient outcome by modifying
surgical techniques or approaching patients with predicted bad outcome to
alternative treatment options. Vaginal microcirculation can be evaluated using
sidestream dark-field (SDF) imaging. We propose a study to investigate the
intra- and inter-observer agreement in the assessment of vaginal capillary
density using SDF imaging followed by a pilot study to assess the effects of
vaginal prolapse on vaginal microcirculation. After this, we will investigate
the best time interval for measurement of microcirculatory parameters after
vaginal prolapse surgery.
Study objective
1. To investigate the intra- and inter-observer agreement in the assessment of
vaginal capillary density using SDF imaging.
2. To investigate whether between patients with and without pelvic organ
prolapse (POP) and in the compartment with and without POP within the same POP
patient differences exist in microcirculatory parameters.
3. To determine the best time interval to measure microcirculatory parameters
after vaginal prolapse surgery with a first assessment of the effects of
prolapse surgery on microcirculatory parameters.
Study design
A prospective pilot study
Study burden and risks
Measurements will be performed in an outpatient clinic of a teaching hospital,
pre-operative and 2 weeks and 3 months post-operative. Each measurement will
take 15 minutes. Patients will be counseled before the measurements and
informed consent will be obtained. The imaging probe will be covered with a
sterile disposable cap. The measurement technique is painless and will cause no
harm.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing primary prolapse surgery because of vaginal prolapse stage 2 or more
Exclusion criteria
Previous pelvic floor surgery
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 | NL44321.018.13 |