Recruiting

Observational Study

Sponsor:

Abington Memorial Hospital

Code:

NCT01926756

Conditions

Postoperative Bacteriuria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Straight catheterization

No straight catheterization

Study Details

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.

Conditions

Postoperative Bacteriuria

Study ID

NCT01926756

Start date

Jul, 2013

Status verified date

Aug, 2013

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Straight catheterization (control)

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

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.

Interventions

Straight catheterization

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

No straight catheterization

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

Primary outcome measure

  • Postoperative Bacteriuria [ Time Frame: 2 -4 weeks ]

Central Contacts and Locations

Central contacts

Emily G Parent, D.O.

215-481-7663eparent@amh.org

Victoria Myers, M.D.

215-481-8379vmyers@amh.org

Locations

Abington Memorial Hospital

Recruiting

Abington, Pennsylvania, United States, 19001

Contacts

Emily Parent, D.O.

215-481-7663eparent@amh.org

Joel Polin, M.D.

215-481-4211JPolin@amh.org

More Information

Sponsor

Abington Memorial Hospital

Last update posted

Aug 21, 2013

Last verified

Aug, 2013

Keywords

  • bacteriuria
  • straight catheterization
  • urinary tract infections
  • iatrogenic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abington Memorial Hospital on 2013-08-21.