NCT04172389

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 26, 2019

Status Verified

October 1, 2019

Enrollment Period

Same day

First QC Date

November 16, 2019

Last Update Submit

November 25, 2019

Conditions

Vesico-vaginal Fistula

Outcome Measures

Primary Outcomes (1)

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

    1 years

Interventions

vesico-vaginal fistula robot assisted laparoscopic repairPROCEDURE

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

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent a robotic vesico-vaginal fistula repair

You may qualify if:

  • presence of a vesico-vaginal fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

centralHNF

Nancy, Grand Est, 54000, France

RECRUITING

MeSH Terms

Conditions

Vesicovaginal Fistula

Condition Hierarchy (Ancestors)

Vaginal FistulaVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder FistulaUrinary FistulaUrogenital AbnormalitiesUrinary Bladder DiseasesUrologic DiseasesGenital DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • pierre lecoanet

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

pierre lecoanet

CONTACT

+33663282607p.lecoanet@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2019

First Posted

November 21, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 31, 2019

Last Updated

November 26, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)