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Perigee versus voorwandplastiek 

 

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

  

OBJECTIVE:

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 DESIGN:

This study is a multicenter, randomized controlled trial.

 

STUDY POPULATION:

Inclusion criteria:

Women undergoing primary or secondary surgical repair of cystocele stage 2 or higher, according to the POP-Q classification.

Exclusion criteria:

Patients with an indication for posterior vaginal wall repair.

Patients with an indication for hysterectomy.

Patients in whom the anterior vaginal wall is not the most descending part of the prolapse.

 

INTERVENTION:

Women are either allocated to classic anterior colporraphy repair or to cystocele using Perigee.

 

OUTCOME MEASURES (performed at 6 weeks, 3 months and 12 months after surgery):

Primary outcome:

Quality of life related to pelvic floor function

Secondary outcome:

Morbidity

POP-Q classification of the prolapse

General quality of life

 

POWER / DATA ANALYSIS:

A difference in reduction of the prolapse domain score (of the UDI) between both surgical techniques of 20% (9 points) is considered to be a clinically relevant difference between the groups. With a power of 90% and an level of 0.05, the calculated sample size necessary is 38 in each group. With an estimated drop-out of 15%, a total of 45 women have to be randomized.

 

TIME-SCHEDULE:

Start inclusion: july 2006 in Leuven, January 2007 in Amsterdam, expected finish of inclusion: April 2008, follow up (12 months) until April 2009.

 

PROJECTLEADER:

Dr. JP Roovers, AMC Amsterdam

Prof. Dr. D. de Ridder, UZ Gasthuisberg, Leuven 

CONTACT:

Dr. J.P. Roovers: J.P.Roovers@amc.uva.nl

 

SUBSIDY:

none.