To investigate the feasibility of SDF imaging and spectrophotometry of the vaginal wall.
ID
Source
Brief title
Condition
- Vulvovaginal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A new approach to measure vaginal microcirculation and oxygenation by
investigating the feasibility of SDF imaging and spectrophotometry of the
vaginal wall.
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 vascularisation of the vagina.
Whether this damage is reversible or not has never been studied. Neither is
known what the effects of surgical damage to vaginal vascularisation are on
oxygenation of the vagina, and whether these effects depend on patient- and
surgery- related characteristics.
Improved understanding of the effects of vaginal prolapse surgery on vaginal
vascularisation and oxygenation may ultimately improve patient outcome by
modifying surgical techniques or approaching patients with predicted bad
outcome to alternative treatment options. Vaginal vascularisation
(microcirculation) can be evaluated using sidestream dark-field (SDF) imaging
and oxygenation of the vaginal wall can be measured using reflectance
spectrophotometry (O2C). We propose a pilot study to investigate the
feasibility of SDF imaging and spectrophotometry in the vagina.
Study objective
To investigate the feasibility of SDF imaging and spectrophotometry of the
vaginal wall.
Study design
A 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. Both measurement techniques are 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
In other registers
Register | ID |
---|---|
CCMO | NL40476.018.12 |
OMON | NL-OMON23498 |