Status:

COMPLETED

The Use of Dye-less Cystoscopy in Assessing Urinary Tract Integrity During Hysterectomy

Lead Sponsor:

WellSpan Health

Conditions:

Hysterectomy

Cystoscopy

Eligibility:

FEMALE

18-90 years

Phase:

NA

Brief Summary

An investigation comparing the reliability of dye-aided versus dye-less evaluation of urinary tract integrity during intra-operative cystoscopy among patients undergoing hysterectomy.

Detailed Description

Surgical injury to the urinary bladder and ureters is a recognized hazard with gynecologic procedures. Overall incidence is low; however, undetected injury to the bladder or ureter can be associated w...

Eligibility Criteria

Inclusion

  • Subjects at least 18 years of age and less than 90 years of age able to give informed consent
  • Subjects undergoing hysterectomy for benign or malignant indications

Exclusion

  • Pregnancy or planned fertility
  • Inability to provide informed consent
  • Subject is not a surgical candidate

Key Trial Info

Start Date :

July 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 29 2019

Estimated Enrollment :

276 Patients enrolled

Trial Details

Trial ID

NCT05190939

Start Date

July 1 2018

End Date

December 29 2019

Last Update

March 17 2023

Active Locations (1)

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Wellspan Health

York, Pennsylvania, United States, 17403