To assess the effects of vaginal prolapse surgery on microcirculatory parameters measured in the vaginal wall with the use of incident dark field (IDF) imaging (Cytocam).
ID
Source
Brief title
Condition
- Vulvovaginal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in measurements of microcirculatory parameters in patients with POP
before and after vaginal surgery.
Secondary outcome
Not applicable
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. Improved
understanding of the effects of vaginal prolapse surgery on vaginal
vascularization may ultimately improve patient outcome by modifying surgical
techniques or approaching patients with predicted bad outcome to alternative
treatment options
Study objective
To assess the effects of vaginal prolapse surgery on microcirculatory
parameters measured in the vaginal wall with the use of incident dark field
(IDF) imaging (Cytocam).
Study design
An observational pilot study.
Study burden and risks
Measurements will be performed in a teaching hospital. 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 prolapse surgery because of vaginal prolapse stage 2 or more in either the anterior or posterior compartment.
Exclusion criteria
1. Cardiovascular disease (e.g. angina pectoris, hypertension)
2. Inflammatory disease (e.g. rheumatoid arthritis, eczema)
3. Other systemic illness (e.g. (non-) insulin dependent diabetes mellitus)
4. Medications (e.g. anticoagulants, anti-inflammatory, or immunosuppressive agents) that could influence the microcirculation
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 | NL49122.018.14 |