ClinicalTrials.gg
Status unknownNCT04172389FFVLAROUpdated Nov 26, 2019

Treatment of Vesico-vaginal Fistula by a Robot Assisted Laparoscopy : Results of a Multicentric Series (FFVLARO)

An observational study in Vesico-vaginal Fistula, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to female participants. Per ClinicalTrials.gov, last updated 2019-11-26.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
15
Sex
Female
01

Study 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.

02

Conditions studied

  • Vesico-vaginal Fistula
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who underwent a robotic vesico-vaginal fistula repair

Inclusion criteria

  • presence of a vesico-vaginal fistula

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
15 participants (estimated)
Patient registry
No

Interventions

  • Procedurevesico-vaginal fistula robot assisted laparoscopic repair

    realization of O'conor technique or extra-vesical technique for vaginal vesico fistula repair in robot assisted coelioscopy

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What researchers measure

Primary outcomes

  1. Presence of urinary leakage through the vagina post surgery after the removal of the urinary tube

    Time frame: 1 years

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2019; primary completion for Dec 2019, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2019
First posted
Nov 21, 2019
StartEst.
Dec 1, 2019
Primary completionEst.
Dec 1, 2019
CompletionEst.
Dec 31, 2019
Last update
Nov 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04172389
Responsible party
Sponsor
First posted
Nov 21, 2019
Start date
Dec 1, 2019 (estimated)
Primary completion
Dec 1, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Nov 26, 2019

Study contacts

pierre lecoanet
Contact
p.lecoanet@chru-nancy.fr
+33663282607
pierre lecoanet
principal investigator · Central Hospital, Nancy, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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