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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Vaginal fixation Amreich-Richter
* Procedure: Prolift total


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female sex age 18 and more subscribed informed consent objective symptoms of prolapse-POP-Q 3 and more according to ICS standards compliance of the patient Exclusion Criteria: patients with evidence of malignant lesion in small pelvis history of radiotherapy in small pelvis patients suffering from any form of PID within inclusion process pregnancy lactation total eversion of uterus and vagina serious internal disorders history of recto- or vesico-vaginal fistula history of rejection of any artificial material symptoms of primary genuine stress urinary incontinence patients who were not able to subscribe the informed consent patients, who couldn´t be reached for further follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly | Procedure: Vaginal fixation Amreich-Richter<br>* Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament<br>|
| Active Comparator: B<br>Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly | Procedure: Prolift total<br>* Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space<br>* Other names: Prolift total - polypropylen mesh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants. |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biocompatible Materials, Female, Humans, Pelvic Floor, Polypropylenes, Prostheses and Implants, Surgical Mesh, Uterine Prolapse/*therapy