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

NCT02971800 | Completed Results DMC

• 1 other identifier: FLUO-HTL
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Injury

Keywords

sodium fluorescein; ureteral efflux; laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire

  after cystoscopy (up to 15 min after injection)

Study Arms (1)

sodium fluorescein

EXPERIMENTAL

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%

Interventions

sodium fluorescein injection 10% DRUG

Also known as: Fluorescite, National Drug Code (NDC) 0065-0092-65

sodium fluorescein

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• total laparoscopic hysterectomy

You may not qualify if:

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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Québec

Québec, G1V 4G2, Canada

Location

MeSH Terms

Interventions

Fluorescein

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr Philippe Laberge
• Organization: CHU de Québec

philippe.laberge@fmed.ulaval.ca

+1(418)525-4444

Study Officials

• Philippe Y Laberge, doctorate

  CHU de Quebec

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologist

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 23, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)