No registrations found.
ID
Source
Brief title
Health condition
Symptomatic cystocele
(NLD: Symptomatische cystocele).
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life related to pelvic floor function.
Secondary outcome
1. Morbidity;
2. POP-Q classification of the prolapse;
3. General quality of life.
Background summary
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.
Study objective
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.
Study design
6 weeks, 3 months and 12 months after surgery.
Intervention
Women are either allocated to classic anterior colporraphy repair or to cystocele using PerigeeTM.
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
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
Inclusion criteria
Women undergoing primary or secondary surgical repair of cystocele stage 2 or higher, according to the POP-Q classification.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1099 |
| NTR-old | NTR1134 |
| Other | MEC : 06/264 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |