Evaluation of Sodium Fluorescein Use During Intraoperative Cystoscopy After Total Laparoscopic Hysterectomy

March 7, 2021 updated by: Dr Philippe Y Laberge, CHU de Quebec-Universite Laval
The primary objective is to describe the safety and efficacy of intravenous sodium fluorescein to visualize ureteral efflux during intraoperative cystoscopy after total laparoscopic hysterectomy. Secondary objective is to report on surgeon's satisfaction with the overall use of sodium fluorescein.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty patients (n=30) ongoing a total laparoscopic hysterectomy in a tertiary gynecological reference center will be included in this prospective descriptive study.Once hysterectomy is completed, a 10 % solution of sodium fluorescein at a 0,25 ml dose will be injected before performing diagnostic cystoscopy. Time from injection to fluorescent visualization will be recorded as well as coloration density. Adverse events are collected in the operating room, in the recovery room, before patient's discharge and through a home survey.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G2
        • CHU de Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • total laparoscopic hysterectomy

Exclusion Criteria:

  • breastfeeding
  • renal insufficiency
  • Medication: Probenecid, digoxin, quinidine, beta-blocker
  • hypersensitivity or intolerance to sodium fluorescein

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sodium fluorescein

Once hysterectomy completed, a 10 % solution of sodium fluorescein at a 0,25 ml dose (25 mg) is injected before performing diagnostic cystoscopy for all patient.

Name: Fluorescite Injection 10%, contains sodium fluorescein (equivalent to fluorescein 10% w/v) Dosage : 25 mg Frequency: only once
Drug: sodium fluorescein injection 10%
Other Names:
  • Fluorescite
  • National Drug Code (NDC) 0065-0092-65

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire
Time Frame: within 15 minutes after the beginning of cystoscopy
Time of visualisation of turbulence, time of visualisation of coloration and quality of ureteral efflux coloration (clearly visible or somewhat visible or not visible)
within 15 minutes after the beginning of cystoscopy
Adverse Reaction Related to Sodium Fluorescein Injection
Time Frame: From sodium fluorescein injection to follow-up 2 months after surgery
From sodium fluorescein injection to follow-up 2 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire
Time Frame: after cystoscopy (up to 15 min after injection)
For each participant, surgeon had 3 options to evaluate their satisfaction regarding ureteral efflux coloration with sodium fluorescein during the surgery : very satisfied or satisfied or unacceptable
after cystoscopy (up to 15 min after injection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Investigators

  • Principal Investigator: Philippe Y Laberge, doctorate, CHU de Québec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 7, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FLUO-HTL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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