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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03517202
Other study ID # 7001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 13, 2018
Est. completion date June 2018

Study information

Verified date March 2018
Source University Hospital, Strasbourg, France
Contact Valentina FAITOT, MD
Phone 03 88 12 70 75
Email valentina.faitot@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 260
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service d'Anesthésiologie - Réanimation Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Patients hospitalized at Strasbourg University Hospital from 2012 to 2016. The period from January 1st, 2012 to December 31st, 2016 will be examined
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