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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04172389
Other study ID # 2019PI229
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date December 31, 2019

Study information

Verified date October 2019
Source Central Hospital, Nancy, France
Contact pierre lecoanet
Phone +33663282607
Email p.lecoanet@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 31, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- presence of a vesico-vaginal fistula

Exclusion Criteria:

-

Study Design


Intervention

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

Locations

Country Name City State
France centralHNF Nancy Grand EST

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of urinary leakage through the vagina post surgery after the removal of the urinary tube 1 years
See also
  Status Clinical Trial Phase
Completed NCT00923338 - Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug N/A