Early or Late Foley Removal After Thoracotomy

NCT ID: NCT01611519

Last Updated: 2016-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

375 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Urinary Tract Infections

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Early (within 48 hours of surgery)

Patients will have their urinary catheter removed within 48 hours of surgery

No interventions assigned to this group

Late (6 hours after epidural removal)

Patients will have their urinary catheter removed 6 hours after their epidural is removed

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mark Allen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34184246 (View on PubMed)

Other Identifiers

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11-006618

Identifier Type: -

Identifier Source: org_study_id

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