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Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?

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ClinicalTrials.gov Identifier: NCT01926756
Recruitment Status : Unknown
Verified August 2013 by Emily G. Parent, D.O., Abington Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : August 21, 2013
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Emily G. Parent, D.O., Abington Memorial Hospital

Tracking Information
First Submitted Date  ICMJE August 19, 2013
First Posted Date  ICMJE August 21, 2013
Last Update Posted Date August 21, 2013
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
Postoperative Bacteriuria [ Time Frame: 2 -4 weeks ]
Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
Subjective urinary tract discomfort [ Time Frame: 2-4 weeks postoperatively ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 20, 2013)
Symptomatic urinary tract infection [ Time Frame: 2-4 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?
Official Title  ICMJE Intraoperative One-Time Catheterization in Short Gynecologic Procedures and Its Potential Effect on Symptomatic and Asymptomatic Bacteriuria
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Bacteriuria
Intervention  ICMJE
  • Procedure: Straight catheterization
    Patient will receive the current standard practice of straight catheterization intraoperatively.
  • Procedure: No straight catheterization
    Patients will not be catheterized which is an experimental change from the current practice at our hospital.
Study Arms  ICMJE
  • Straight catheterization (control)
    The control arm is the current practice at our hospital (to perform straight catheterization for short procedures).
    Intervention: Procedure: Straight catheterization
  • Active Comparator: No straight catheterization
    The experimental arm will void preoperatively and will not be straight catheterized intraoperatively. This is a change from the current practice at our hospital.
    Intervention: Procedure: No straight catheterization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 20, 2013)
200
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01926756
Other Study ID Numbers  ICMJE AMH-Myers/Parent001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emily G. Parent, D.O., Abington Memorial Hospital
Study Sponsor  ICMJE Abington Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily G Parent, D.O. Abington Memorial Hospital
PRS Account Abington Memorial Hospital
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP