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OpenTrials
Completed

NCT Number: NCT01261819

"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

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.

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Key information

Conditions

Lower Urinary Tract Injury

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Florida Hospital

Winter Park and Celebration, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cystoscopy

Device

Primary outcomes

  1. Time Required to Perform Procedure (in Seconds)

    Time frame: During Procedure (Up to 15 minutes)

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

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 17, 2010
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.