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

November 25, 2019 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent a robotic vesico-vaginal fistula repair

Description

Inclusion Criteria:

  • presence of a vesico-vaginal fistula

Exclusion Criteria:

-

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of urinary leakage through the vagina post surgery after the removal of the urinary tube
Time Frame: 1 years
1 years

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: pierre lecoanet, Central Hospital, Nancy, France

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 (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

November 16, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019PI229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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