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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

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.

Condition or disease Intervention/treatment Phase
Postoperative Bacteriuria Procedure: Straight catheterization Procedure: No straight catheterization Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Intraoperative One-Time Catheterization in Short Gynecologic Procedures and Its Potential Effect on Symptomatic and Asymptomatic Bacteriuria
Study Start Date : July 2013
Estimated Primary Completion Date : June 2014

Arm Intervention/treatment
Straight catheterization (control)
The control arm is the current practice at our hospital (to perform straight catheterization for short procedures).
Procedure: Straight catheterization
Patient will receive the current standard practice of straight catheterization intraoperatively.

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.
Procedure: No straight catheterization
Patients will not be catheterized which is an experimental change from the current practice at our hospital.




Primary Outcome Measures :
  1. Postoperative Bacteriuria [ Time Frame: 2 -4 weeks ]
    Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.


Secondary Outcome Measures :
  1. Subjective urinary tract discomfort [ Time Frame: 2-4 weeks postoperatively ]

Other Outcome Measures:
  1. Symptomatic urinary tract infection [ Time Frame: 2-4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926756


Contacts
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Contact: Emily G Parent, D.O. 215-481-7663 eparent@amh.org
Contact: Victoria Myers, M.D. 215-481-8379 vmyers@amh.org

Locations
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United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Emily Parent, D.O.    215-481-7663    eparent@amh.org   
Contact: Joel Polin, M.D.    215-481-4211    JPolin@amh.org   
Sponsors and Collaborators
Abington Memorial Hospital
Investigators
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Principal Investigator: Emily G Parent, D.O. Abington Memorial Hospital

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Responsible Party: Emily G. Parent, D.O., OB/GYN Resident Physician PGY-IV, Abington Memorial Hospital
ClinicalTrials.gov Identifier: NCT01926756     History of Changes
Other Study ID Numbers: AMH-Myers/Parent001
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013
Keywords provided by Emily G. Parent, D.O., Abington Memorial Hospital:
bacteriuria
straight catheterization
urinary tract infections
iatrogenic
Additional relevant MeSH terms:
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Bacteriuria
Urinary Tract Infections
Infection
Urologic Diseases