"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy in Patients Undergoing Minimally Invasive Hysterectomy: A Prospective Comparison Study

The study aimed to compare the use of a transurethral laparoscope to the use of a traditional cystoscope for evaluation of the bladder and ureters at the time of laparoscopic hysterectomy. The hypothesis was that visual inspection of the bladder and ureters can be done safely using a transurethral laparoscope, takes less time than traditional cystoscopy, and is more cost effective than traditional cystoscopy.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Injury
• Intervention / Treatment: Device: cystoscopy

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Winter Park And Celebration, Florida, United States
      • Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. any female patient scheduled for a laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH) with or without adnexectomy for benign disease
2. able to comprehend and sign the informed consent form
3. able to provide clean-catch urine specimens
4. able to complete a urinary symptom questionnaire pre- and post-operatively

Exclusion Criteria:

1. participants in another research protocol involving an investigational product 30 days before planned randomization
2. pregnant women
3. patients undergoing concomitant incontinence or pelvic support procedures (e.g. transvaginal tape, transobturator tape, pelvic organ prolapse surgery)
4. patients known to have a history of recurrent urinary tract infections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transurethral laparoscope; These patients had cystoscopy performed with the transurethral laparoscope.	Device: cystoscopy
Active Comparator: Traditional cystoscopy; These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."	Device: cystoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Required to Perform Procedure (in Seconds)	Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy.	During Procedure (Up to 15 minutes)

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: Katherine Kratz, M.D., AdventHealth

Publications and helpful links

General Publications

• Kratz KG, Spytek SH, Caceres A, Lukman R, McCarus SD. A randomized, single-blinded pilot study evaluating use of a laparoscope or a cystoscope for cystoscopy during gynecologic surgery. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):606-14. doi: 10.1016/j.jmig.2012.06.002. Epub 2012 Jul 17.

Helpful Links

• Publication of study

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: December 16, 2010
• First Posted (Estimate): December 17, 2010

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: cystoscopy, minimally invasive hysterectomy
• Other Study ID Numbers: FH Project #2142-4860