"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

NCT01261819 | Completed Results

• 1 other identifier: FH Project #2142-4860
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Injury

Keywords

cystoscopy, minimally invasive hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

transurethral laparoscope

EXPERIMENTAL

These patients had cystoscopy performed with the transurethral laparoscope.

Device: cystoscopy

Traditional cystoscopy

ACTIVE COMPARATOR

These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."

Device: cystoscopy

Interventions

cystoscopy DEVICE

Traditional cystoscopy; transurethral laparoscope

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Florida Hospital

Winter Park and Celebration, Florida, United States

Location

Related Publications (1)

• 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.

  PMID: 22818539 DERIVED

Related Links

• Publication of study

MeSH Terms

Interventions

Cystoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Results Point of Contact

• Title: Katherine Kratz, M.D.
• Organization: Florida Hospital

katiegoodrich@gmail.com

Study Officials

• Katherine Kratz, M.D.

  AdventHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: December 17, 2010
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

US (1)