This 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…
ID
Bron
Verkorte titel
Aandoening
Symptomatic cystocele
(NLD: Symptomatische cystocele).
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Quality of life related to pelvic floor function.
Achtergrond van het onderzoek
After 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.
Doel van het onderzoek
This 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.
Onderzoeksopzet
6 weeks, 3 months and 12 months after surgery.
Onderzoeksproduct en/of interventie
Women are either allocated to classic anterior colporraphy repair or to cystocele using PerigeeTM.
Publiek
Jan-Paul W.R. Roovers
Department of Obstetrics and Gynaecology
Academic Medical Center (AMC)
Meibergdreef 9, H4-140-1
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666429
j.p.roovers@amc.uva.nl
Wetenschappelijk
Jan-Paul W.R. Roovers
Department of Obstetrics and Gynaecology
Academic Medical Center (AMC)
Meibergdreef 9, H4-140-1
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666429
j.p.roovers@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Women undergoing primary or secondary surgical repair of cystocele stage 2 or higher, according to the POP-Q classification.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1099 |
| NTR-old | NTR1134 |
| Ander register | MEC : 06/264 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |