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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium fluorescein injection 10% | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Y Laberge, doctorate | CHU de Quebec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Québec | Québec | G1V 4G2 | Canada |
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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)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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% |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Count of Participants | Participants | within 15 minutes after the beginning of cystoscopy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Partial ureteral obstruction | Injury, poisoning and procedural complications | Non-systematic Assessment | 1 participant had a partial ureteral obstruction (13 days after surgery) even if a normal ureteral patency was initially diagnosed. However, the gap between the two jets was the longest observed (6 minutes) in our cohort. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sustained nausea | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Philippe Laberge | CHU de Québec | +1(418)525-4444 | philippe.laberge@fmed.ulaval.ca |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Number evaluable participant already reached |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body mass index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Surgery duration (min) | Mean | Standard Deviation | minutes |
|
| Uterus Weight (g) | Mean | Standard Deviation | gram |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Adverse Reaction Related to Sodium Fluorescein Injection | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | after cystoscopy (up to 15 min after injection) |
|
|
|
| 0 |
| 30 |
| 3 |
| 30 |
| 17 |
| 30 |
|
| Vault hematoma | Surgical and medical procedures | Non-systematic Assessment |
|
| partial vaginal cuff dehiscence | Surgical and medical procedures | Systematic Assessment |
|
| Yellowish skin coloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Persistant fluorescent urine coloration | Renal and urinary disorders | Systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|
|
| Itching |
|
| Yellowish skin coloration |
|