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Clinical Trials/NCT03127280
NCT03127280CompletedNot Applicable

Can Investigators Reduce Urinary Catheter Use and Lower Urinary Tract Infection Among Women Undergoing Benign Gynecologic Surgery?

The Christ Hospital1 site in 1 country200 target enrollmentStarted: November 4, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Locations
1
Primary Endpoint
Foley Duration

Study Overview

Brief Summary

This is a randomized comparative trial investigating two different catheter management strategies among post-gynecologic surgery patients. Women undergoing any benign gynecologic surgery wherein they are anticipated to stay at least overnight and in whom no prolapse or urinary tract surgery was concurrently performed, will be randomly assigned to either conventional urinary catheter care removal on post-operative day 1 or same day surgery urinary catheter removal. Patient satisfaction and lower urinary tract symptoms including urine culture and antibiotic use will be tracked across both cohorts over the 2 weeks following the index surgery.

Detailed Description

METHODS:

This study will be conducted at The Christ Hospital. Informed consent will be obtained from the patients in the pre-operative care unit prior to administration of any medications. Candidates for the study will clearly understand consenting to enroll in the study includes not only the randomized assignment of urinary catheter care postoperatively but also a follow-up phone survey to be administered approximately 2 weeks after discharge. Patient reasons for not enrolling in the study will be recorded.

Study population All women presenting to The Christ Hospital for gynecologic surgery anticipated to require an at least 1 night stay and in whom would be expected to have an indwelling catheter overnight are eligible to participate in the study. Patients with a current urinary tract infection being treated with antibiotic(s), anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a history of chronic indwelling catheter use, a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged postoperative catheter use are to excluded from study participation. Following application of the inclusion and exclusion criteria, postoperative urinary catheter care (conventional vs. fast track) will randomized upon arrive to the postoperative care unit (PACU). These patients will compose the study population.

Protocol:

Per routine anesthesia practice once a patient has met criteria for discharge from the PACU, and following randomization into either the conventional or fast track cohorts, the subject will either have immediate removal of the catheter with a trial of void or the catheter will remain in place over night per routine practice with a trial of void arranged at the time of discharge.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •All women, over the age of 18, presenting to The Christ Hospital for gynecologic surgery anticipated to require an at least 1 night stay and in whom would be expected to have an indwelling catheter overnight are eligible to participate in the study.

Exclusion Criteria

  • •Patients with a current urinary tract infection being treated with antibiotic(s), anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a history of chronic indwelling catheter use, a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged postoperative catheter use are to excluded from study participation.

Arms & Interventions

Conventional Foley Care

No Intervention

Following surgery, the patient's Foley catheter is removed on the morning of post-operative day one.

Fast Tract Foley care

Experimental

Following surgery, the patient's Foley catheter is removed on post-operative day zero, four hours after the completion of surgery.

Intervention: Fast Track foley removal (Other)

Outcomes

Primary Outcomes

Foley Duration

Time Frame: Between 4 hours after surgery completion to 24 hours after surgery completion

Determine the duration (in hours) of urinary catheter use between conventional urinary catheter care and "fast track" urinary catheter care among women undergoing benign gynecologic surgery not involving lower urinary tract surgery or pelvic organ prolapse repair.

Secondary Outcomes

  • Patient satisfaction(2-3 weeks after surgery)
  • Incidence of urinary tract infection(2-3 weeks after surgery)
  • Voiding dysfunction(Between 4 hours after surgery completion to 24 hours after surgery completion.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Patrick Lang

Fellow Physician

The Christ Hospital

Study Sites (1)

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