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Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery


N/A
18 Years
N/A
Open (Enrolling)
Female
Pelvic Organ Prolapse, Gynecologic Cancers, Uterine Leiomyomata, Adenomyosis, Endometrial Hyperplasia, Other Abnormal Uterine and Vaginal Bleeding, Pelvic Mass, Pelvic Pain

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Trial Information

Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery

Inclusion Criteria


Inclusion Criteria

- age 18 or older

- plan to have one of the following types of surgery:

- laparoscopic or abdominal gynecological surgery

- vaginal surgery

- able to provide written informed consent

Exclusion Criteria

- under 18 years of age

- bilateral tubal ligation as the single reason for surgery

- current pregnancy

- unable to provide written informed consent

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

bladder and ureter sounds during pelvic surgery.

Outcome Time Frame:

from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)

Safety Issue:

Yes

Principal Investigator

Stuart Hart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Florida

Authority:

United States: Institutional Review Board

Study ID:

USF IRB 00001841

NCT ID:

NCT01463462

Start Date:

February 2011

Completion Date:

Related Keywords:

  • Pelvic Organ Prolapse
  • Gynecologic Cancers
  • Uterine Leiomyomata
  • Adenomyosis
  • Endometrial Hyperplasia
  • Other Abnormal Uterine and Vaginal Bleeding
  • Pelvic Mass
  • Pelvic Pain
  • Endometrial Hyperplasia
  • Hemorrhage
  • Hyperplasia
  • Leiomyoma
  • Myofibroma
  • Pelvic Pain
  • Prolapse
  • Uterine Hemorrhage
  • Adenoma
  • Pelvic Organ Prolapse

Name

Location
Women's Center Operating Rooms at the Tampa General Hospital Tampa, Florida  33606