Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03719755
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2018-10-19
Brief Title:
Urinary Tract Infections Rates Using 50 Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Comparison of Urinary Tract Infections Rates Using 50 Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid a Prospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 100000 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 positivePrimary 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 100000 gram-negative colony-forming units per milliliter
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 positivePrimary 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 100000 gram-negative colony-forming units per milliliter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None