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Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-Obturator Way for the Correction of Anterior Prolapse

NCT00859417 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2019-05-28

No results posted yet for this study

Summary

The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In front of the high rate of recurrences with this technique, the use of synthetic prosthesis made their appearance. But the drawback of the use of prosthesis is their tolerability. The system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high efficiency in the correction of the prolapse while reducing the risk of complications. The lack of prospective and randomized studies makes difficult to assess the interest. The investigators, therefore, have put in place a randomized prospective study seeking the evaluation of the system Perigee® compared to the conventional surgical technique.

Conditions

  • Anterior Prolapse

Interventions

PROCEDURE

Traditional surgery

Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).

DEVICE

Perigee® prosthesis

Surgical method with Perigee® prosthesis

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • MELLIER Georges, MD · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00859417 on ClinicalTrials.gov