N/A
N=66
"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy
Lower Urinary Tract Injury
Bottom Line
View on ClinicalTrials.gov: NCT01261819 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Time Required to Perform Procedure (in Seconds) — 137; 451 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- cystoscopy (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- AdventHealth
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Required to Perform Procedure (in Seconds) |
137; 451 | — |
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.
Eligibility Criteria
Inclusion Criteria
- any female patient scheduled for a laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH) with or without adnexectomy for benign disease
- able to comprehend and sign the informed consent form
- able to provide clean-catch urine specimens
- able to complete a urinary symptom questionnaire pre- and post-operatively
Exclusion Criteria
- participants in another research protocol involving an investigational product 30 days before planned randomization
- pregnant women
- patients undergoing concomitant incontinence or pelvic support procedures (e.g. transvaginal tape, transobturator tape, pelvic organ prolapse surgery)
- patients known to have a history of recurrent urinary tract infections
Data sourced from ClinicalTrials.gov (NCT01261819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.