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

July 31, 2009 updated by: Charles University, Czech Republic

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 12800
        • Recruiting
        • Dpt. Obstetrics and gynecology, General Teaching Hospital
        • Contact:
      • Prague, Czech Republic, 147 10
        • Recruiting
        • Institute for the Care of Mother and Child
        • Contact:
      • Prague, Czech Republic, 169 02
        • Recruiting
        • Dpt. of gynecology, Central military hospital
        • Contact:
      • Prague, Czech Republic, 18000
        • Recruiting
        • Dpt. Obstetrics and gynecology, Teaching hospital Bulovka
        • Contact:
      • Zlin, Czech Republic, 762 75
        • Recruiting
        • Dpt. of Obstetrics and gynecology, Bata hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

Ministry of Health, Czech Republic

Investigators

  • Principal Investigator: Michael Halaska, MD,PhD, Charles University, Prague, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria

December 12, 2007

First Posted (Estimate)

December 13, 2007

Study Record Updates

Last Update Posted (Estimate)

August 3, 2009

Last Update Submitted That Met QC Criteria

July 31, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR/9309-3 IGA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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