Evaluation of Sodium Fluorescein Use During Intraoperative Cystoscopy After Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •total laparoscopic hysterectomy
排除标准
- •breastfeeding
- •renal insufficiency
- •Medication: Probenecid, digoxin, quinidine, beta-blocker
- •hypersensitivity or intolerance to sodium fluorescein
研究组 & 干预措施
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
干预措施: sodium fluorescein injection 10% (Drug)
结局指标
主要结局
Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire
时间窗: 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
时间窗: From sodium fluorescein injection to follow-up 2 months after surgery
次要结局
- Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire(after cystoscopy (up to 15 min after injection))
研究者
Dr Philippe Y Laberge
Gynecologist
CHU de Quebec-Universite Laval