Trial Outcomes & Findings for Evaluation of Sodium Fluorescein Use During Intraoperative Cystoscopy After Total Laparoscopic Hysterectomy (NCT NCT02971800)

NCT ID: NCT02971800

Last Updated: 2021-04-01

Results Overview

Time of visualisation of turbulence, time of visualisation of coloration and quality of ureteral efflux coloration (clearly visible or somewhat visible or not visible)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: within 15 minutes after the beginning of cystoscopy
• Results posted on: 2021-04-01

Participant Flow

37 participants signed informed consent 1 patient excluded - protocol violation (had laparotomy instead of anticipated laparoscopy) 1 patient - withdrawal by subject before surgery 1 patient - excluded before surgery (took an unauthorized drug) 4 patients - excluded before surgery (number needed (30) already reached)

Participant milestones

Measure	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 sodium fluorescein injection 10%
Overall Study STARTED	37
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	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 sodium fluorescein injection 10%
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1
Overall Study Exclusion criteria prior intervention	1
Overall Study Number evaluable participant already reached	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sodium Fluorescein n=30 Participants 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 sodium fluorescein injection 10%
Age, Continuous	46 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Canada	30 Participants n=5 Participants
Body mass index (kg/m^2)	25 kg/m^2 STANDARD_DEVIATION 4 • n=5 Participants
Surgery duration (min)	141 minutes STANDARD_DEVIATION 47 • n=5 Participants
Uterus Weight (g)	320 gram STANDARD_DEVIATION 218 • n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Sodium Fluorescein n=30 Participants 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 sodium fluorescein injection 10%
Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire Bilateral Coloration clearly visible	23 Participants
Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire Unilateral Coloration clearly visible and unilateral somewhat visible	4 Participants
Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire Unilateral Coloration clearly visible (unilateral not visible and no turbulence)	1 Participants
Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire Bilateral Coloration somewhat visible	1 Participants
Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire Bilateral Coloration not visible (bilateral turbulence)	1 Participants

PRIMARY outcome

Timeframe: From sodium fluorescein injection to follow-up 2 months after surgery

Outcome measures

Measure	Sodium Fluorescein n=30 Participants 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 sodium fluorescein injection 10%
Adverse Reaction Related to Sodium Fluorescein Injection Post-administration hypotension requiring medication	3 Participants
Adverse Reaction Related to Sodium Fluorescein Injection Sustained nausea in recovery room	1 Participants
Adverse Reaction Related to Sodium Fluorescein Injection Persistant fluorescent urine coloration at 48 hours	15 Participants
Adverse Reaction Related to Sodium Fluorescein Injection Itching	3 Participants
Adverse Reaction Related to Sodium Fluorescein Injection Yellowish skin coloration	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Sodium Fluorescein n=30 Participants 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 sodium fluorescein injection 10%
Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire Very satisfied	27 Participants
Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire Satisfied	2 Participants
Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire Unacceptable	1 Participants

Adverse Events

Sodium Fluorescein

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sodium Fluorescein n=30 participants at risk 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 sodium fluorescein injection 10%
Injury, poisoning and procedural complications Partial ureteral obstruction	3.3% 1/30 • Number of events 1
Surgical and medical procedures Vault hematoma	3.3% 1/30 • Number of events 1
Surgical and medical procedures partial vaginal cuff dehiscence	3.3% 1/30 • Number of events 1

Other adverse events

Measure	Sodium Fluorescein n=30 participants at risk 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 sodium fluorescein injection 10%
General disorders Sustained nausea	3.3% 1/30 • Number of events 1
Skin and subcutaneous tissue disorders Yellowish skin coloration	3.3% 1/30 • Number of events 1
Skin and subcutaneous tissue disorders Itching	10.0% 3/30 • Number of events 3
Vascular disorders Hypotension	10.0% 3/30 • Number of events 3
Renal and urinary disorders Persistant fluorescent urine coloration	50.0% 15/30 • Number of events 15

Additional Information

Dr Philippe Laberge

CHU de Québec

Phone: +1(418)525-4444

Email: philippe.laberge@fmed.ulaval.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place