NCT00572702

Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure

Open, Randomized, Prospective, Comparative, Multicentric to Treat Prolapse of Vaginal Cuff After Hysterectomy With Amreich Procedure or Total Prolift Procedure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Head to Head comparison of perioperative complications and secondary the impact of operation techniques with or without mesh on patients suffering from pelvic organ prolapse on quality of life.

Detailed description

During the last decade a substantial progress in the detailed knowledge of morphology and function of different compartments of the female pelvic floor was achieved. The obtained informations were quickly implemented in the clinical practice especially in the application of special meshes and of novel techniques of their implantation. Their success rate was evaluated only in pilot companies supported studies. We do miss randomised studies not sponsored by company comparing different surgical techniques and their impact on the quality of life (QoL); the objective estimation of those consequences is for the longlasting effect of the surgery inevitable. The new methods bring also new complications which were not yet relevantly and objectively documented. In the study we compare the techniques contemporary used - in the groups with or without mesh, in size relevant for the statistical evaluation

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Vaginal fixation Amreich-Richter	Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
PROCEDURE	Prolift total	Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-12-13
• Last updated: 2009-08-03

Locations

5 sites across 1 country: Czechia