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OpenTrials
Completed

NCT Number: NCT02971800

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

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.

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Key information

Conditions

Ureteral Injury

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Québec

Québec, G1V 4G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • total laparoscopic hysterectomy

Exclusion criteria

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

Treatment and study plan

sodium fluorescein injection 10%

Drug

Other names: Fluorescite, National Drug Code (NDC) 0065-0092-65

Primary outcomes

  1. Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire

    Time frame: 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)

  2. Adverse Reaction Related to Sodium Fluorescein Injection

    Time frame: 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

    Time frame: after cystoscopy (up to 15 min after injection)

    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

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 23, 2016
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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