Transobturator Repair by Vaginal Plastron (CYSPTO)

February 14, 2023 updated by: Hospices Civils de Lyon

Transobturator Cystocele Repair by Vaginal Plastron

The autologous vaginal route consists of repairing the genital prolapse through the vagina using the patient's tissues without a prosthesis. Vaginal prostheses are actually currently prohibited in France [1, 2].

The autologous vaginal route is the quickest surgery and it can be done under spinal anesthesia, which constitutes arguments for offering it to elderly and fragile patients. The autologous vaginal approach gives functional and subjective results similar to promontofixation [2].

There are many surgical techniques that make it difficult to assess the recurrence rate in the literature. Autologous vaginal surgery provides a good degree of satisfaction for patients despite the risk of recurrence [3].

We propose to describe the results of the transobturator cystocele repair by vaginal plastron, a technique which seems reproducible and effective to us.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

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

  • France
    • Bron
      • Lyon, Bron, France, 69500
        • Hôpital Femme Mère Enfant

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This study covers all patients who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse between September 2020 and October 2022.

Description

Inclusion Criteria:

  • women over 18
  • patient who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse requiring surgical correction of stage equal to or greater than II in the POP-Q classification
  • intervention between September 2020 and October 2022
  • person having expressed his non-opposition

Exclusion Criteria:

  • inability to understand the information given
  • person deprived of liberty
  • person under guardianship

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
transobturator cystocele repair by vaginal plastron
patients who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse
Procedure: correction of anterior prolapse
percentage of failed prolapse correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
failed prolapse correction
Time Frame: at 1 month after surgery
percentage of failed prolapse correction
at 1 month after surgery

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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 (Actual)

October 13, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Estimate)

February 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-5083
  • 69HCL22_1180 (Other Identifier: HCL)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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