search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


A randomized controlled trial of anterior colporraphy and PerigeeTM as surgical correction of symptomatic cystocele.


- candidate number2891
- NTR NumberNTR1134
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2007
- Secondary IDs06/264 MEC
- Public TitleA randomized controlled trial of anterior colporraphy and PerigeeTM as surgical correction of symptomatic cystocele.
- Scientific TitleA randomized controlled trial of anterior colporraphy and PerigeeTM as surgical correction of symptomatic cystocele.
- ACRONYMPerigee trial
- hypothesisThis trial hypothesizes that there are differences in morbidity and efficacy between both surgical techniques. It is also hypothesized that PerigeeTM is less morbid compared to anterior colporraphy as it is a minimal invasive technique. We can not hypothesize on the efficacy of the compared techniques.
- Healt Condition(s) or Problem(s) studiedSymptomatic cystocele
- Inclusion criteriaWomen undergoing primary or secondary surgical repair of cystocele stage 2 or higher, according to the POP-Q classification.
- Exclusion criteria1. Patients with an indication for posterior vaginal wall repair;
2. Patients with an indication for hysterectomy;
3. Patients in whom the anterior vaginal wall is not the most descending part of the prolapse.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2006
- planned closingdate1-apr-2009
- Target number of participants90
- InterventionsWomen are either allocated to classic anterior colporraphy repair or to cystocele using PerigeeTM.
- Primary outcomeQuality of life related to pelvic floor function.
- Secondary outcome1. Morbidity;
2. POP-Q classification of the prolapse;
3. General quality of life.
- Timepoints6 weeks, 3 months and 12 months after 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), Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Obstetrics and Gynecology
- PublicationsN/A
- Brief summaryAfter a standard surgical anterior colporrhaphy for an anterior vaginal wall prolapse (cystocele) grade 2 or higher, one-third of women will have an anatomical recurrence within 2 years after primary surgery. The use of a non-absorbable synthetic polypropylene mesh that is applied by a transobturator approach appears to be effective. However there is a lack of randomized controlled trials comparing this new approach to conventional anterior colporraphy. The purpose of this randomized controlled trial is to compare the effects of anterior colporraphy and PerigeeTM as surgical correction of symptomatic cystocele.
- Main changes (audit trail)
- RECORD18-nov-2007 - 3-apr-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl