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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ureteral Injury

Intervention / Treatment
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* Drug: sodium fluorescein injection 10%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: total laparoscopic hysterectomy Exclusion Criteria: breastfeeding renal insufficiency Medication: Probenecid, digoxin, quinidine, beta-blocker hypersensitivity or intolerance to sodium fluorescein

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium fluorescein<br>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%<br> <br> * Other names: National Drug Code (NDC) 0065-0092-65;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire | 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 |  | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sodium fluorescein, ureteral efflux, laparoscopic hysterectomy