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Completed

NCT Number: NCT01611519

Early or Late Foley Removal After Thoracotomy

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

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Development of urinary tract infection

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2012
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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