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Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?

NCT ID: NCT01926756

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Postoperative Bacteriuria

Keywords

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bacteriuria straight catheterization urinary tract infections iatrogenic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Straight catheterization (control)

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

Group Type OTHER

Straight catheterization

Intervention Type PROCEDURE

Patient will receive the current standard practice of straight catheterization intraoperatively.

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.

Group Type ACTIVE_COMPARATOR

No straight catheterization

Intervention Type PROCEDURE

Patients will not be catheterized which is an experimental change from the current practice at our hospital.

Interventions

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Straight catheterization

Patient will receive the current standard practice of straight catheterization intraoperatively.

Intervention Type PROCEDURE

No straight catheterization

Patients will not be catheterized which is an experimental change from the current practice at our hospital.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Abington Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Emily G. Parent, D.O.

OB/GYN Resident Physician PGY-IV

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily G Parent, D.O.

Role: PRINCIPAL_INVESTIGATOR

Abington Memorial Hospital

Locations

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Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily G Parent, D.O.

Role: CONTACT

Phone: 215-481-7663

Email: [email protected]

Victoria Myers, M.D.

Role: CONTACT

Phone: 215-481-8379

Email: [email protected]

Facility Contacts

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Emily Parent, D.O.

Role: primary

Joel Polin, M.D.

Role: backup

Other Identifiers

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AMH-Myers/Parent001

Identifier Type: -

Identifier Source: org_study_id