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Een gerandomiseerde studie waarin voorwandherstel, RAz suspensie en Perigee als chirurgische correctie van een blaasverzakking worden vergeleken.


- candidate number2867
- NTR NumberNTR1125
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-nov-2007
- Secondary IDsML3550 - EC- UZKULeuven University Hospitals K.U.Leuven, Pelvic floor centre
- Public TitleEen gerandomiseerde studie waarin voorwandherstel, RAz suspensie en Perigee als chirurgische correctie van een blaasverzakking worden vergeleken.
- Scientific TitleA randomized controlled trial of anterior colporraphy, Raz four defect repair ad Perigee as surgical correction of symptomatic cystocoele.
- ACRONYMPerigee trial
- hypothesis1. There are differences in morbidity and efficacy between the surgical techniques that are compared in this trial;
2. Perigee induces less morbidity than the other techniques.
- Healt Condition(s) or Problem(s) studiedAnterior Colporrhaphy
- Inclusion criteriaPatients planned for the surgical correction of a cystocoele, with or without incontinence, with or without uterine prolapse.
- Exclusion criteria1. Prolapse less than stage 2;
2. previous cystocoele repair.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-dec-2006
- planned closingdate31-dec-2008
- Target number of participants148
- InterventionsOne of the three types of cystocoele repair: colporraphy anterior, Raz four defect repair or Perigee.
- Primary outcomePost-operative morbidity assessed by a validated questionnaire and a VAS score.
- Secondary outcomeDuration of catheter use.
- TimepointsDisease specific quality of life.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. Dirk Ridder De
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Dirk Ridder De
- Sponsor/Initiator UZ Urologie, Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
American Medical Systems, Inc.
- PublicationsN/A
- Brief summaryThis trial will compare funtional outcome of three different vaginal operations for symptomatic cystocoele: anterior colporaphy, Perigee mesh implant, Raz four defect repair.
- Main changes (audit trail)
- RECORD8-nov-2007 - 3-apr-2008


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