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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Charles University, Czech Republic.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, Czech Republic
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00572702
First received: December 12, 2007
Last updated: July 31, 2009
Last verified: July 2009

December 12, 2007
July 31, 2009
January 2007
December 2009   (final data collection date for primary outcome measure)
The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants. [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00572702 on ClinicalTrials.gov Archive Site
Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]
ultrasound,urodynamics, clinical examinations, magnetic resonance imaging,validated QoL questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure
Open, Randomized, Prospective, Comparative, Multicentric to Treat Prolapse of Vaginal Cuff After Hysterectomy With Amreich Procedure or Total Prolift Procedure

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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pelvic Organ Prolapse
  • Procedure: Vaginal fixation Amreich-Richter
    Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
  • Procedure: Prolift total
    Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space
    Other Name: Prolift total - polypropylen mesh
  • Active Comparator: A
    Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly
    Intervention: Procedure: Vaginal fixation Amreich-Richter
  • Active Comparator: B
    Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly
    Intervention: Procedure: Prolift total
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Michael Krcmar, MD +420607675842 xkrcmar@centrum.cz
Contact: Kamil Svabik, MD +420603583456 kamil@svabik.cz
Czech Republic
 
NCT00572702
NR/9309-3 IGA, NR/9309-3 IGA
No
prof. Michael Halaska, MD., PhD., Inner Grant Agency, Ministry of Health, Czech republic
Charles University, Czech Republic
Ministry of Health, Czech Republic
Principal Investigator: Michael Halaska, MD,PhD Charles University, Prague, Czech Republic
Charles University, Czech Republic
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP