"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

AdventHealth66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Lower Urinary Tract Injury

Interventions

cystoscopyDEVICE

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Florida Hospital

Winter Park and Celebration, Florida, United States

Outcomes

Primary Outcomes

Time Required to Perform Procedure (in Seconds)

Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy.

Time frame: During Procedure (Up to 15 minutes)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.