Duration of Stay After Urologic Surgery : Neuraxial Versu... | NCT03517202

Studies
Duration of Stay After Urologic Surgery : Neuraxial Versus General Anesthesia

NCT03517202

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jun 4, 2018Actual

Enrollment

260Estimated

Phase

Not provided

Conditions

Urinary Retention

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 13, 2018Actual

Primary Completion Date

Jun 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Apr 24, 2018

First Submission Date that Met QC Criteria

Apr 24, 2018

First Posted Date

May 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2018

Last Update Posted Date

Jun 4, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Outcomes Module

Primary Outcomes

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.	Patients hospitalized at Strasbourg University Hospital from 2012 to 2016.	The period from January 1st, 2012 to December 31st, 2016 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Valentina FAITOT, MD	Contact	03 88 12 70 75		valentina.faitot@chru-strasbourg.fr
Gauthier VINEE, MD	Contact	03 88 12 70 75		gauthieremmanuel.vinee@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Valentina FAITOT, MD	University Hospital, Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Anesthésiologie - Réanimation	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D016055	Urinary Retention
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided