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Clinical Trials/NCT03719755
NCT03719755
Completed
Not Applicable

Comparison of Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid: a Prospective Study

Mayo Clinic1 site in 1 country152 target enrollmentFebruary 1, 2018
ConditionsHysterectomy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hysterectomy
Sponsor
Mayo Clinic
Enrollment
152
Locations
1
Primary Endpoint
rates of urinary tract infections at 6-9 days post-operative
Status
Completed
Last Updated
last year

Overview

Brief Summary

Our study will compare the rates of postoperative urinary tract infections (UTI) between patients who undergo cystoscopy using 50% dextrose injection plus bladder washout versus normal saline after hysterectomy for benign indications. Primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

Detailed Description

This will be a prospective cohort study of the rate of UTIs after cystoscopic distention media of normal saline with maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications. A pre-operative urine culture will be obtained via mid-stream clean catch prior to administration of routine pre-operative prophylactic antibiotics. At 6-9 days post-operatively, a repeat urine culture will be obtained via mid-stream clean catch. Appropriate treatment will be administered if the urine culture is positive.Primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
December 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Johnny Yi

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Preoperative scheduling CPT codes for hysterectomy

Exclusion Criteria

  • Discharged home with indwelling foley catheter
  • Indwelling foley catheter \> 24 hours
  • Ureteral injury
  • Chronic immunosuppression
  • History of diabetes
  • Recurrent UTIs (≥2 infections in six months or ≥3 infections in one year)
  • Reported Chronic Kidney Disease
  • Renal anomalies

Outcomes

Primary Outcomes

rates of urinary tract infections at 6-9 days post-operative

Time Frame: 6-9 days post-operative

be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter

Study Sites (1)

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