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
  Purpose

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 Intervention
Pelvic Organ Prolapse
Procedure: Vaginal fixation Amreich-Richter
Procedure: Prolift total

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

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. [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Prolift total - polypropylen mesh

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572702

Contacts
Contact: Michael Krcmar, MD +420607675842 xkrcmar@centrum.cz
Contact: Kamil Svabik, MD +420603583456 kamil@svabik.cz

Locations
Czech Republic
Dpt. Obstetrics and gynecology, General Teaching Hospital Recruiting
Prague, Czech Republic, 12800
Contact: Kamil Svabik, MD.    +420603583456    kamil@svabik.cz   
Dpt. Obstetrics and gynecology, Teaching hospital Bulovka Recruiting
Prague, Czech Republic, 18000
Contact: Michal Krcmar, MD.    +420607675842    xkrcmar@centrum.cz   
Dpt. of gynecology, Central military hospital Recruiting
Prague, Czech Republic, 169 02
Contact: Tomas Rittstein, MD.    +420606369793    urogyn@volny.cz   
Institute for the care of mother and child Recruiting
Prague, Czech Republic, 147 10
Contact: Ladislav Krofta, MD.,PhD.    +420604480886    ladislav.krofta@post.cz   
Dpt. of Obstetrics and gynecology, Bata hospital Recruiting
Zlin, Czech Republic, 762 75
Contact: Zdenek Adamik, MD., PhD.    +420603241176    adamik@mediclub.cz   
Sponsors and Collaborators
Charles University, Czech Republic
Ministry of Health, Czech Republic
Investigators
Principal Investigator: Michael Halaska, MD,PhD Charles University, Prague, Czech Republic
  More Information

No publications provided

Responsible Party: prof. Michael Halaska, MD., PhD., Inner Grant Agency, Ministry of Health, Czech republic
ClinicalTrials.gov Identifier: NCT00572702     History of Changes
Other Study ID Numbers: NR/9309-3 IGA, NR/9309-3 IGA
Study First Received: December 12, 2007
Last Updated: July 31, 2009
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:
Biocompatible Materials
Female
Humans
Pelvic Floor
Polypropylenes
Prostheses and Implants
Surgical Mesh
Uterine Prolapse/*therapy

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 29, 2014