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

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Vaginal fixation Amreich-Richter
Prolift total
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Biocompatible Materials, Female, Humans, Pelvic Floor, Polypropylenes, Prostheses and Implants, Surgical Mesh, Uterine Prolapse/*therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dpt. Obstetrics and gynecology, General Teaching HospitalRecruiting
  • Institute for the care of mother and childRecruiting
  • Dpt. of gynecology, Central military hospitalRecruiting
  • Dpt. Obstetrics and gynecology, Teaching hospital BulovkaRecruiting
  • Dpt. of Obstetrics and gynecology, Bata hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly

Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly

Outcomes

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.

Secondary Outcome Measures

Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires

Full Information

First Posted
December 12, 2007
Last Updated
July 31, 2009
Sponsor
Charles University, Czech Republic
Collaborators
Ministry of Health, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT00572702
Brief Title
Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure
Official Title
Open, Randomized, Prospective, Comparative, Multicentric to Treat Prolapse of Vaginal Cuff After Hysterectomy With Amreich Procedure or Total Prolift Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Charles University, Czech Republic
Collaborators
Ministry of Health, Czech Republic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Biocompatible Materials, Female, Humans, Pelvic Floor, Polypropylenes, Prostheses and Implants, Surgical Mesh, Uterine Prolapse/*therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly
Arm Title
B
Arm Type
Active Comparator
Arm Description
Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly
Intervention Type
Procedure
Intervention Name(s)
Vaginal fixation Amreich-Richter
Intervention Description
Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
Intervention Type
Procedure
Intervention Name(s)
Prolift total
Other Intervention Name(s)
Prolift total - polypropylen mesh
Intervention Description
Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Krcmar, MD
Phone
+420607675842
Email
xkrcmar@centrum.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Kamil Svabik, MD
Phone
+420603583456
Email
kamil@svabik.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Halaska, MD,PhD
Organizational Affiliation
Charles University, Prague, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt. Obstetrics and gynecology, General Teaching Hospital
City
Prague
ZIP/Postal Code
12800
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamil Svabik, MD.
Phone
+420603583456
Email
kamil@svabik.cz
Facility Name
Institute for the care of mother and child
City
Prague
ZIP/Postal Code
147 10
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ladislav Krofta, MD.,PhD.
Phone
+420604480886
Email
ladislav.krofta@post.cz
Facility Name
Dpt. of gynecology, Central military hospital
City
Prague
ZIP/Postal Code
169 02
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Rittstein, MD.
Phone
+420606369793
Email
urogyn@volny.cz
Facility Name
Dpt. Obstetrics and gynecology, Teaching hospital Bulovka
City
Prague
ZIP/Postal Code
18000
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Krcmar, MD.
Phone
+420607675842
Email
xkrcmar@centrum.cz
Facility Name
Dpt. of Obstetrics and gynecology, Bata hospital
City
Zlin
ZIP/Postal Code
762 75
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zdenek Adamik, MD., PhD.
Phone
+420603241176
Email
adamik@mediclub.cz

12. IPD Sharing Statement

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

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