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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00572702
• Other study ID #: NR/9309-3 IGA
• Secondary ID: NR/9309-3 IGA
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2007
• Last updated: July 31, 2009
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2009
• Source: Charles University, Czech Republic
• Contact: Michael Krcmar, MD
• Phone: +420607675842
• Email: xkrcmar[@]centrum.cz
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Vaginal fixation Amreich-Richter
Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
• Prolift total
Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space

Locations

Country	Name	City	State
Czech Republic	Dpt. Obstetrics and gynecology, General Teaching Hospital	Prague
Czech Republic	Dpt. Obstetrics and gynecology, Teaching hospital Bulovka	Prague
Czech Republic	Dpt. of gynecology, Central military hospital	Prague
Czech Republic	Institute for the care of mother and child	Prague
Czech Republic	Dpt. of Obstetrics and gynecology, Bata hospital	Zlin

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Ministry of Health, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants.		3 month	No
Secondary	Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires		1 year	No