Ureteral Injury
Conditions
Keywords
sodium fluorescein, ureteral efflux, laparoscopic hysterectomy
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.
Detailed 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.
Interventions
DRUGsodium fluorescein injection 10%
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* total laparoscopic hysterectomy
Exclusion criteria
* breastfeeding * renal insufficiency * Medication: Probenecid, digoxin, quinidine, beta-blocker * hypersensitivity or intolerance to sodium fluorescein
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire | 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 | From sodium fluorescein injection to follow-up 2 months after surgery | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire | 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 |
Countries
Canada
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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% | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Exclusion criteria prior intervention | 1 |
| Overall Study | Number evaluable participant already reached | 4 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Sodium Fluorescein |
|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 5 |
| Body mass index (kg/m^2) | 25 kg/m^2 STANDARD_DEVIATION 4 |
| Region of Enrollment Canada | 30 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
| Surgery duration (min) | 141 minutes STANDARD_DEVIATION 47 |
| Uterus Weight (g) | 320 gram STANDARD_DEVIATION 218 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 17 / 30 |
| serious Total, serious adverse events | 3 / 30 |
Outcome results
Primary
Adverse Reaction Related to Sodium Fluorescein Injection
Time frame: From sodium fluorescein injection to follow-up 2 months after surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sodium Fluorescein | Adverse Reaction Related to Sodium Fluorescein Injection | Post-administration hypotension requiring medication | 3 Participants |
| Sodium Fluorescein | Adverse Reaction Related to Sodium Fluorescein Injection | Sustained nausea in recovery room | 1 Participants |
| Sodium Fluorescein | Adverse Reaction Related to Sodium Fluorescein Injection | Persistant fluorescent urine coloration at 48 hours | 15 Participants |
| Sodium Fluorescein | Adverse Reaction Related to Sodium Fluorescein Injection | Itching | 3 Participants |
| Sodium Fluorescein | Adverse Reaction Related to Sodium Fluorescein Injection | Yellowish skin coloration | 1 Participants |
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)
Time frame: within 15 minutes after the beginning of cystoscopy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sodium Fluorescein | Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire | Bilateral Coloration clearly visible | 23 Participants |
| Sodium Fluorescein | Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire | Unilateral Coloration clearly visible and unilateral somewhat visible | 4 Participants |
| Sodium Fluorescein | Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire | Unilateral Coloration clearly visible (unilateral not visible and no turbulence) | 1 Participants |
| Sodium Fluorescein | Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire | Bilateral Coloration somewhat visible | 1 Participants |
| Sodium Fluorescein | Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire | Bilateral Coloration not visible (bilateral turbulence) | 1 Participants |
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
Time frame: after cystoscopy (up to 15 min after injection)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sodium Fluorescein | Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire | Very satisfied | 27 Participants |
| Sodium Fluorescein | Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire | Satisfied | 2 Participants |
| Sodium Fluorescein | Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire | Unacceptable | 1 Participants |