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A new approach to measure vaginal microcirculation.


- candidate number12898
- NTR NumberNTR3484
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jun-2012
- Secondary IDsNL40476.018.12 / 2012_109; CCMO / METC AMC
- Public TitleA new approach to measure vaginal microcirculation.
- Scientific TitleA new approach to measure vaginal microcirculation.
- ACRONYMVAMP study
- hypothesisVaginal 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 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.
- Healt Condition(s) or Problem(s) studiedProlapse, Surgery, Microcirculation, Vagina
- Inclusion criteriaPatients undergoing primary prolapse surgery because of vaginal prolapse stage 2 or more.
- Exclusion criteriaPrevious pelvic surgery.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-jun-2012
- planned closingdate15-jun-2013
- Target number of participants50
- InterventionsMeasurements will be performed in eight different target areas (proximal and distal in four different directions) by two researchers before and after local administration of 1:200.000 diluted adrenaline.
- Primary outcomeFeasibility of SDF imaging and spectrophotometry of the vaginal wall.
- Secondary outcomeThe interobserver reproducibility of SDF imaging and spectrophotometry of the vaginal wall. Differences in measurements of SDF imaging and spectrophotometry between the proximal and distal part of the vagina, and between the anterior and posterior wall of the vagina.
- TimepointsMeasurements will be performed under general anesthesia right before the start of surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Jan-Paul W.R. Roovers
- CONTACT for SCIENTIFIC QUERIESMD, PhD Jan-Paul W.R. Roovers
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryRationale:
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 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.

Objective:
1. To investigate the feasibility of SDF imaging and spectrophotometry of the vaginal wall;
2. To investigate the interobserver reproducibility of SDF imaging and spectrophotometry of the vaginal wall;
3. To investigate whether between the proximal and distal part of the vagina, and between the anterior and posterior wall of the vagina, differences exist in SDF imaging and spectrophotometry of the vaginal wall.

Study design:
A cross-sectional pilot study.

Study population:
Patients scheduled for primary vaginal prolapse surgery because of vaginal prolapse stage 2 or more (ICS classification).

Main study parameters/endpoints:
Primary outcome: Feasibility of SDF imaging and spectrophotometry of the vaginal wall. Secondary outcome: The interobserver reproducibility of SDF imaging and spectrophotometry of the vaginal wall. Differences in measurements of SDF imaging and spectrophotometry between the proximal and distal part of the vagina, and between the anterior and posterior wall of the vagina.
Measurements will be performed in eight different target areas (proximal and distal in four different directions) by two researchers before and after local administration of 1:200.000 diluted adrenaline.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Measurements will be performed under general anesthesia therefore causing no extra burden. Surgery time will be prolonged with 5 minutes and there is no expectation that this prolongation will influence the morbidity risks of the procedure. Patients will be counseled before the measurements and informed consent will be obtained. Measurements will not influence the procedure. Local administration of 1:200.000 diluted adrenaline in the vaginal wall will not harm the patient.
- Main changes (audit trail)
- RECORD14-jun-2012 - 1-jul-2012


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