Skip to main content
Clinical Trials/NCT01926756
NCT01926756
Unknown
Not Applicable

Intraoperative One-Time Catheterization in Short Gynecologic Procedures and Its Potential Effect on Symptomatic and Asymptomatic Bacteriuria

Abington Memorial Hospital1 site in 1 country200 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Bacteriuria
Sponsor
Abington Memorial Hospital
Enrollment
200
Locations
1
Primary Endpoint
Postoperative Bacteriuria
Last Updated
12 years ago

Overview

Brief Summary

This is a prospective randomized controlled trial to look into the reduction of catheter associated urinary tract infections in the postoperative period. It will specifically look at short gynecologic procedures such as D&C (dilation and curettage), hysteroscopies and LEEP procedures and the need to perform intraoperative catheterization. If a patient urinates immediately before a short operation then there is no need to drain the bladder with a catheter during the procedure. The investigators hypothesize that eliminating catheterization during these short procedures may decrease postoperative urinary tract infections. The hope is that this study would provide evidence to support a change in practice.

Detailed Description

The majority of research currently concentrates on indwelling catheters rather than one-time catheterization. Current practice at our institution in the gynecologic operating room is to perform a one time catheterization on patient's undergoing short procedures, yet it is unclear if this is a necessary intervention. If patients are asked to void immediately before their procedure it would eliminate the need for intra-operative catheterization and eliminate a potential source of infection. The study is designed to determine whether routine catheterization prior to a minor OB/GYN procedure causes symptomatic or asymptomatic bacteria in the urine. Current practice is one-time catheterization of patients undergoing minor OB/GYN procedures prior to the beginning of the procedure. The investigators hypothesize that this causes asymptomatic or symptomatic bacteriuria.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
June 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily G. Parent, D.O.

OB/GYN Resident Physician PGY-IV

Abington Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • The patient must be 18 years of age or older.
  • The patient must be female.
  • The patient must be undergoing a same-day gynecologic procedure where catheterization is usually performed.
  • The patient must have general anesthesia or monitored anesthesia care (MAC). This includes IV sedation.

Exclusion Criteria

  • The patient cannot be undergoing intermittent one-time catheterization.
  • The patient can not have had an indwelling catheter placed in the past 6 months.
  • The patients cannot have a concomitant pelvic infection.
  • The procedure cannot require spinal anesthesia.
  • The patient cannot be taking immunosuppressive medications.
  • The patient cannot be taking antibiotics and/or suppressive therapy for chronic urinary tract infections.
  • The patient cannot receive pre-operative or intra-operative antibiotics.

Outcomes

Primary Outcomes

Postoperative Bacteriuria

Time Frame: 2 -4 weeks

Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.

Secondary Outcomes

  • Subjective urinary tract discomfort(2-4 weeks postoperatively)

Study Sites (1)

Loading locations...

Similar Trials