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Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?

Primary Purpose

Postoperative Bacteriuria

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Straight catheterization
No straight catheterization
Sponsored by
Abington Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Bacteriuria focused on measuring bacteriuria, straight catheterization, urinary tract infections, iatrogenic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Abington Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Straight catheterization (control)

No straight catheterization

Arm Description

The control arm is the current practice at our hospital (to perform straight catheterization for short procedures).

The experimental arm will void preoperatively and will not be straight catheterized intraoperatively. This is a change from the current practice at our hospital.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective urinary tract discomfort

Full Information

First Posted
August 19, 2013
Last Updated
August 20, 2013
Sponsor
Abington Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01926756
Brief Title
Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?
Official Title
Intraoperative One-Time Catheterization in Short Gynecologic Procedures and Its Potential Effect on Symptomatic and Asymptomatic Bacteriuria
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abington Memorial Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Bacteriuria
Keywords
bacteriuria, straight catheterization, urinary tract infections, iatrogenic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Straight catheterization (control)
Arm Type
Other
Arm Description
The control arm is the current practice at our hospital (to perform straight catheterization for short procedures).
Arm Title
No straight catheterization
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Straight catheterization
Intervention Description
Patient will receive the current standard practice of straight catheterization intraoperatively.
Intervention Type
Procedure
Intervention Name(s)
No straight catheterization
Intervention Description
Patients will not be catheterized which is an experimental change from the current practice at our hospital.
Primary Outcome Measure Information:
Title
Postoperative Bacteriuria
Description
Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.
Time Frame
2 -4 weeks
Secondary Outcome Measure Information:
Title
Subjective urinary tract discomfort
Time Frame
2-4 weeks postoperatively
Other Pre-specified Outcome Measures:
Title
Symptomatic urinary tract infection
Time Frame
2-4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily G Parent, D.O.
Phone
215-481-7663
Email
eparent@amh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Myers, M.D.
Phone
215-481-8379
Email
vmyers@amh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily G Parent, D.O.
Organizational Affiliation
Abington Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Parent, D.O.
Phone
215-481-7663
Email
eparent@amh.org
First Name & Middle Initial & Last Name & Degree
Joel Polin, M.D.
Phone
215-481-4211
Email
JPolin@amh.org

12. IPD Sharing Statement

Learn more about this trial

Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?

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