Conditions: Ureteral Injury
Keywords: sodium fluorescein ureteral efflux laparoscopic hysterectomy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 37
Healthy volunteers: yes

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.

Arms:
arm 1: 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

Interventions: intervention 1: sodium fluorescein injection 10%
Intervention descriptions: intervention 1: None

Protocol document: