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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space
Dpt. Obstetrics and gynecology, General Teaching Hospital
Prague, Czechia
RECRUITINGInstitute for the care of mother and child
Prague, Czechia
RECRUITINGDpt. of gynecology, Central military hospital
Prague, Czechia
The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants.
Time frame: 3 month
Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires
Time frame: 1 year
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Dpt. Obstetrics and gynecology, Teaching hospital Bulovka
Prague, Czechia
RECRUITINGDpt. of Obstetrics and gynecology, Bata hospital
Zlín, Czechia
RECRUITING