"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

Not Applicable

Completed

• Conditions: Lower Urinary Tract Injury
• Interventions: Device: cystoscopy

• Registration Number: NCT01261819
• Lead Sponsor: AdventHealth

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Status Verified: 2020-09
• Results First Submitted: 2020-09-16
• Results First Submitted QC: 2020-09-16
• Last Update Submitted: 2020-09-16
• Results First Posted: 2020-10-08
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transurethral laparoscope	cystoscopy	These patients had cystoscopy performed with the transurethral laparoscope.
Traditional cystoscopy	cystoscopy	These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."

Primary Outcome Measures

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

Trial Locations

Locations (1)

Florida Hospital; 🇺🇸 Winter Park And Celebration, Florida, United States