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Early or Late Foley Removal After Thoracotomy

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ClinicalTrials.gov Identifier: NCT01611519
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Mark Allen, Mayo Clinic

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

Condition or disease
Urinary Tract Infections

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.

Study Type : Observational
Actual Enrollment : 375 participants
Time Perspective: Prospective
Official Title: Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial
Study Start Date : December 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. Need for insertion of catheter after Foley removed. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]

Secondary Outcome Measures :
  1. Development of urinary tract infection [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing thoracic surgery at the Mayo Clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611519


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Allen, MD Mayo Clinic

Responsible Party: Mark Allen, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01611519     History of Changes
Other Study ID Numbers: 11-006618
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mark Allen, Mayo Clinic:
urinary bladder
urinary catheterization
epidural analgesia
catheters, indwelling

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases