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
Recruitment status was Recruiting
Sponsor:
Charles University, Czech Republic
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
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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
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, Teaching hospital Bulovka | Recruiting |
| Prague, Czech Republic, 18000 | |
| Contact: Michal Krcmar, MD. +420607675842 xkrcmar@centrum.cz | |
| Dpt. Obstetrics and gynecology, General Teaching Hospital | Recruiting |
| Prague, Czech Republic, 12800 | |
| Contact: Kamil Svabik, MD. +420603583456 kamil@svabik.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 gynecology, Central military hospital | Recruiting |
| Prague, Czech Republic, 169 02 | |
| Contact: Tomas Rittstein, MD. +420606369793 urogyn@volny.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:
|
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013