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

Ureteral Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971800
• Other study ID #: FLUO-HTL
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: April 2017

Study information

• Verified date: March 2021
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• total laparoscopic hysterectomy

Exclusion Criteria:

• breastfeeding

• renal insufficiency

• Medication: Probenecid, digoxin, quinidine, beta-blocker

• hypersensitivity or intolerance to sodium fluorescein

Related Conditions & MeSH terms

• Ureteral Injury

Intervention

Drug:
• sodium fluorescein injection 10%

Locations

Country	Name	City	State
Canada	CHU de Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse Reaction Related to Sodium Fluorescein Injection		From sodium fluorescein injection to follow-up 2 months after surgery
Secondary	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)