Early or Late Foley Removal After Thoracotomy | NCT01611519

Studies
Early or Late Foley Removal After Thoracotomy

NCT01611519

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Sep 13, 2016Estimated

Enrollment

375Actual

Phase

Not provided

Conditions

Urinary Tract Infections

Interventions

Not provided

Countries

United States

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jun 1, 2012

First Submission Date that Met QC Criteria

Jun 4, 2012

First Posted Date

Jun 5, 2012Estimated

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

Sep 12, 2016

Last Update Posted Date

Sep 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery with an epidural catheter in place?

Detailed Description

We hypothesis that removing the foley catheter within 48 hours after a thoracotomy in patients that have an epidural catheter will result in an increase in the rate of urinary infections and the need for reinsertion of the foley. We have designed a randomized trial to test this hypothesis.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

375Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early (within 48 hours of surgery)		Patients will have their urinary catheter removed within 48 hours of surgery
Late (6 hours after epidural removal)		Patients will have their urinary catheter removed 6 hours after their epidural is removed

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Need for insertion of catheter after Foley removed.		participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Development of urinary tract infection		participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

epidural catheter after thoracic surgery
foley in place

Exclusion Criteria:

< 18 years of age
death in hospital within 30 days of the operation
length of hospital stay is less than 48 hours
epidural catheter is removed before the 3rd postoperative day
patients who have a suprapubic catheter or no bladder
patients who require a urologist or a urologic technician to insert the Foley catheter at the time of surgery
patients who were being intermittently catheterized before surgery
patients with a known urinary tract infection preoperatively
patients required to keep Foley in since they required close monitoring of urinary output

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing thoracic surgery at the Mayo Clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Allen, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34184246	Derived	Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications