To Catheterize or Not? in Total Knee Arthroplasty With Co... | NCT02986061

Studies
To Catheterize or Not? in Total Knee Arthroplasty With Combined Spinal-epidural Analgesia

NCT02986061

Sponsor

Southwest Hospital, China

Status

Unknown status

Last Update Posted

Dec 8, 2016Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Urinary Catheter

Interventions

Urinary catheter

Countries

China

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

Dec 2016

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

Nov 2016

Primary Completion Date

Jan 2017Estimated

Completion Date

Not provided

First Submitted Date

Nov 30, 2016

First Submission Date that Met QC Criteria

Dec 7, 2016

First Posted Date

Dec 8, 2016Estimated

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

Dec 7, 2016

Last Update Posted Date

Dec 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of this study was to investigate whether urinary catheterization could be avoided for all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus multi-site infiltration analgesia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	Active Comparator	Patients with indwelling urinary catheter	Device: Urinary catheter
Study Group	No Intervention	Patients without indwelling urinary catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Urinary catheter	Device		Control Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative urinary retention		7 days
Postoperative urinary tract infection		7 days
Urine volume		3 days

Secondary Outcomes

Measure	Description	Time Frame
Length of stay		14 days
Intraoperative intravenous fluid		1 day
Duration of the surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 40 years and older, who were scheduled for a primary TKA for end-stage osteoarthritis and those who were willing and able to return for follow-up over at least a 1-month postoperative period.

Exclusion Criteria:

Revisions, bilateral procedures, surgical history of urinary system, urinary tract infection and systematical conditions (renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery) needing intraoperative monitoring urine output.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei-Nan Zeng, MD	Contact			weinanzeng@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Joint Surgery, Southwest Hospital, Third Military Medical University	Recruiting	Chongqing	Chongqing Municipality	400038	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062885	Urinary Catheters

Ancestor Terms

ID	Term
D057785	Catheters
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided