- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03517202
Duration of Stay After Urologic Surgery : Neuraxial Versus General Anesthesia
May 31, 2018 updated by: University Hospital, Strasbourg, France
Duration of Stay for Outpatient Surgery After Tension Free Vaginal Tape (TVT) Urologic Surgery : Neuraxial Versus General Anesthesia
Outpatient midurethral surgery is a frequent surgery. It is performed either under general anesthesia or neuraxial anesthesia. A frequent complication is postoperative urinary retention requiring urinary catheterization, which implies a higher infectious risk.
The investigators compared the complication rate after TVT surgery depending on the type of anesthesia.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
260
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
- Name: Valentina FAITOT, MD
- Phone Number: 03 88 12 70 75
- Email: valentina.faitot@chru-strasbourg.fr
Study Contact Backup
- Name: Gauthier VINEE, MD
- Phone Number: 03 88 12 70 75
- Email: gauthieremmanuel.vinee@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France, 67091
- Recruiting
- Service d'Anesthésiologie - Réanimation
-
Contact:
- Valentina FAITOT, MD
- Phone Number: 33 3 88 12 70 75
- Email: valentina.faitot@chru-strasbourg.fr
-
Contact:
- Gauthier VINEE, MD
- Phone Number: 33 3 88 12 70 75
- Email: gauthieremmanuel.vinee@chru-strasbourg.fr
-
Principal Investigator:
- Valentina FAITOT, MD
-
Sub-Investigator:
- Gauthier VINEE, MD
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016
Description
Inclusion Criteria:
- Age > 18 years
- Sex: Female
- Patient who has consented to the use of her medical data for research purposes.
- Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016
Exclusion Criteria:
- Specific clinical forms of the disease,
- Interfering treatments and associated diseases, history,
- Refusal of the patient to participate in the study
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: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The investigators compared the rate of complications after TVT surgery depending on the type of anesthesia and the need for urinary catheterization, requiring longer hospital stay after surgery.
Time Frame: The period from January 1st, 2012 to December 31st, 2016 will be examined
|
Patients hospitalized at Strasbourg University Hospital from 2012 to 2016.
|
The period from January 1st, 2012 to December 31st, 2016 will be examined
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Valentina FAITOT, MD, University Hospital, Strasbourg, 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 (Actual)
March 13, 2018
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
April 24, 2018
First Submitted That Met QC Criteria
April 24, 2018
First Posted (Actual)
May 7, 2018
Study Record Updates
Last Update Posted (Actual)
June 4, 2018
Last Update Submitted That Met QC Criteria
May 31, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7001
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.
Clinical Trials on Urinary Retention
-
Rambam Health Care CampusCompleted
-
TriHealth Inc.Completed
-
Lundbeck FoundationCompletedPostoperative Urinary RetentionDenmark
-
Mayo ClinicRecruitingPostoperative Urinary RetentionUnited States
-
Wake Forest University Health SciencesTerminatedUrinary Retention PostoperativeUnited States
-
University of MichiganTerminatedPostoperative Urinary RetentionUnited States
-
University of RochesterTerminatedPost-Operative Urinary RetentionUnited States
-
Rigshospitalet, DenmarkLundbeck FoundationCompletedPostoperative Urinary Retention (POUR)Denmark
-
Anand Rughani, MDMaineHealthCompletedPost-operative Urinary RetentionUnited States
-
University Hospital Inselspital, BerneCompletedPost Operative Urinary RetentionSwitzerland