Vesico-vaginal FistulaFFVLARONCT04172389
Treatment of Vesico-vaginal Fistula by a Robot Assisted Laparoscopy : Results of a Multicentric Series (FFVLARO)
An observational study of Vesico-vaginal Fistula, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Robot-assisted Vesico-Vaginal fistula (VVF) repair was described a few years ago as an alternative to the open approach to minimize the morbidity of this surgery. Very little series have reported the results of robotic VVF repair. The objective of this work was to evaluate the results of robotic VVF repair. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vesico-vaginal Fistula
- What is being tested?
- vesico-vaginal fistula robot assisted laparoscopic repair
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 31 Dec 2019
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent a robotic vesico-vaginal fistula repair
Who may be able to join
- presence of a vesico-vaginal fistula
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
centralHNF
Nancy, Grand Est, 54000
PIERRE LECOANET, p.lecoanet@chru-nancy.fr
About this study
Official title: Multicentric Retrospective Evaluation of the Vesico-vaginal Fistula Repair by Robot Assisted Laparoscopy
Robot-assisted Vesico-Vaginal fistula (VVF) repair was described a few years ago as an alternative to the open approach to minimize the morbidity of this surgery. Very little series have reported the results of robotic VVF repair. The objective of this work was to evaluate the results of robotic VVF repair.
- Conditions
- Vesico-vaginal Fistula
- Being tested
- vesico-vaginal fistula robot assisted laparoscopic repair
- Medical subject headings
- Vesicovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vesico-vaginal fistula robot assisted laparoscopic repairProcedure or surgery
realization of O'conor technique or extra-vesical technique for vaginal vesico fistula repair in robot assisted coelioscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of urinary leakage through the vagina post surgery after the removal of the urinary tube
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vesico-vaginal FistulaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- pierre lecoanet, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172389
- Sponsor's protocol ID
- 2019PI229
- Acronym
- FFVLARO
- Status last verified
- Oct 2019
- First submitted
- 16 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lecoanet P, Madanelo M, Tricard T, Mauger de Varennes A, Haudebert C, Richard C, Hascoet J, Bentellis I, Tibi B, Saussine C, Hubert J, Peyronnet B. Robot-assisted vesicovaginal fistula repair: comparison of the extravesical and transvesical techniques. Int Urogynecol J. 2023 Oct;34(10):2479-2485. doi: 10.1007/s00192-023-05565-7. Epub 2023 May 19.
PubMed 37204473
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Retrospective Evaluation of the Vesico-vaginal Fistula Repair by Robot Assisted Laparoscopy
- ClinicalTrials.gov ID
- NCT04172389
- Acronym / sponsor ID
- FFVLARO / 2019PI229
- Conditions
- Vesico-vaginal Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 21 Nov 2019 (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.
Robot-assisted Vesico-Vaginal fistula (VVF) repair was described a few years ago as an alternative to the open approach to minimize the morbidity of this surgery. Very little series have reported the results of robotic VVF repair. The objective of this work was to evaluate the results of robotic VVF repair.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent a robotic vesico-vaginal fistula repair
Key inclusion criteria (1 listed)
- presence of a vesico-vaginal fistula
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| vesico-vaginal fistula robot assisted laparoscopic repairrealization of O'conor technique or extra-vesical technique for vaginal vesico fistula repair in robot assisted coelioscopy | Procedure or surgery | – |
Primary outcome
Presence of urinary leakage through the vagina post surgery after the removal of the urinary tube
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Derived from this study: PubMed 37204473Lecoanet P, Madanelo M, Tricard T, Mauger de Varennes A, Haudebert C, Richard C, Hascoet J, Bentellis I, Tibi B, Saussine C, Hubert J, Peyronnet B. Robot-assisted vesicovaginal fistula repair: comparison of the extravesical and transvesical techniques. Int Urogynecol J. 2023 Oct;34(10):2479-2485. doi: 10.1007/s00192-023-05565-7. Epub 2023 May 19.
- Individual participant dataSharing planned: No
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.
pierre lecoanet principal investigator
Central Hospital, Nancy, France
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 Vesico-vaginal Fistula, run by Central Hospital, Nancy, France 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact pierre lecoanet (+33663282607, p.lecoanet@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of urinary leakage through the vagina post surgery after the removal of the urinary tube (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04172389, which also lists 1 linked publication.
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 26 Nov 2019.