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

Charles University, Czech Republic

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Vaginal fixation Amreich-Richter; Procedure: Prolift total

Study type: Interventional

Funder types: Other

Identifiers

NCT00572702

NR/9309-3 IGA

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

A

Active Comparator group

Description:

Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly

Treatment:

Procedure: Vaginal fixation Amreich-Richter

B

Active Comparator group

Description:

Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly

Treatment:

Procedure: Prolift total