Pelvic Organ Prolapse Clinical Trial
Official title:
Open, Randomized, Prospective, Comparative, Multicentric to Treat Prolapse of Vaginal Cuff After Hysterectomy With Amreich Procedure or Total Prolift Procedure
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.
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
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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