Clinical trial NCT00572702: Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure
Official title: Open, Randomized, Prospective, Comparative, Multicentric to Treat Prolapse of Vaginal Cuff After Hysterectomy With Amreich Procedure or Total Prolift Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Biocompatible Materials
Female
Humans
Pelvic Floor
Polypropylenes
Prostheses and Implants
Surgical Mesh
Uterine Prolapse/*therapy
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Czech Republic
First posted: 2007-12-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants.
timeFrame: 3 month
Secondary outcomes:
measure: Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires
timeFrame: 1 year
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Dpt. Obstetrics and gynecology, General Teaching Hospital
city: Prague
country: Czech Republic
facility: Institute for the care of mother and child
city: Prague
country: Czech Republic
facility: Dpt. of gynecology, Central military hospital
city: Prague
country: Czech Republic
facility: Dpt. Obstetrics and gynecology, Teaching hospital Bulovka
city: Zlin
country: Czech Republic
facility: Dpt. of Obstetrics and gynecology, Bata hospital
Study officials:
affiliation: Charles University, Prague, Czech Republic
name: Michael Halaska, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: