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

Sponsor

Charles University, Czech Republic (Other)

Overall Status

Unknown status

CT.gov ID

NCT00572702

Collaborator

Ministry of Health, Czech Republic (Other)

200

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Vaginal fixation Amreich-Richter Procedure: Prolift total	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: A

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

Procedure: Vaginal fixation Amreich-Richter

Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament

Active Comparator: B

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

Procedure: Prolift total

Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space

Other Names:

Prolift total - polypropylen mesh

Outcome Measures

Primary Outcome Measures

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

Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Dpt. Obstetrics and gynecology, General Teaching Hospital	Prague	Czech Republic	12800
2	Institute for the care of mother and child	Prague	Czech Republic	147 10
3	Dpt. of gynecology, Central military hospital	Prague	Czech Republic	169 02
4	Dpt. Obstetrics and gynecology, Teaching hospital Bulovka	Prague	Czech Republic	18000
5	Dpt. of Obstetrics and gynecology, Bata hospital	Zlin	Czech Republic	762 75