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

Not Applicable

Completed

• Conditions: Ureteral Injury
• Interventions: Drug: sodium fluorescein injection 10%

• Registration Number: NCT02971800
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief Summary

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.

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-23
• Primary Completion: 2017-01
• Study Completion: 2017-04
• Results First Submitted: 2017-11-02
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-07
• Last Update Submitted: 2021-03-07
• Results First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

• total laparoscopic hysterectomy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sodium fluorescein	sodium fluorescein injection 10%	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

Primary Outcome Measures

Name	Time	Method
Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire	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)
Adverse Reaction Related to Sodium Fluorescein Injection	From sodium fluorescein injection to follow-up 2 months after surgery

Secondary Outcome Measures

Name	Time	Method
Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire	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

Trial Locations

Locations (1)

CHU de Québec; 🇨🇦 Quebec, Canada