Anterior Prolapse Surgery Using the Transobturator Repair by Vaginal PlastronCYSPTONCT05741567
Transobturator Repair by Vaginal Plastron
An observational study of Anterior Prolapse Surgery Using the Transobturator Repair by Vaginal Plastron, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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]. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anterior Prolapse Surgery Using the Transobturator Repair by Vaginal Plastron
- What is being tested?
- correction of anterior prolapse
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- inability to understand the information given
- person deprived of liberty
- person under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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].
Read more
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.
- Being tested
- correction of anterior prolapse
- Keywords
- anterior prolapse, transobturator repair, vaginal plastron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
correction of anterior prolapseProcedure or surgery
percentage of failed prolapse correction
| Study group | Role | What they receive |
|---|---|---|
| transobturator cystocele repair by vaginal plastron | patients who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse Receives: Procedure: correction of anterior prolapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
failed prolapse correction
percentage of failed prolapse correction
Measured: at 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start13 Oct 2022
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Prolapse Surgery Using the Transobturator Repair by Vaginal PlastronStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741567
- Sponsor's protocol ID
- 22-5083
- Other IDs
- 69HCL22_1180
- Acronym
- CYSPTO
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transobturator Cystocele Repair by Vaginal Plastron
- ClinicalTrials.gov ID
- NCT05741567
- Acronym / sponsor ID
- CYSPTO / 22-5083
- Keywords
- anterior prolapse, transobturator repair, vaginal plastron
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transobturator cystocele repair by vaginal plastron | – | Procedure: correction of anterior prolapsepatients who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- inability to understand the information given
- person deprived of liberty
- person under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| correction of anterior prolapsepercentage of failed prolapse correction | Procedure or surgery | transobturator cystocele repair by vaginal plastron |
Primary outcome
failed prolapse correction
Time frame: at 1 month after surgery
percentage of failed prolapse correction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Prolapse Surgery Using the Transobturator Repair by Vaginal Plastron, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failed prolapse correction (time frame: at 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.