N/A
N=37
Evaluation of Sodium Fluorescein Use During Intraoperative Cystoscopy After Total Laparoscopic Hysterectomy
Ureteral Injury
Bottom Line
View on ClinicalTrials.gov: NCT02971800 ↗Enrolled (actual)
37
Serious AEs
10.0%
Results posted
Apr 2021
Primary outcome: Primary: Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire — 23; 4; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- sodium fluorescein injection 10% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- CHU de Quebec-Universite Laval
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire |
23; 4; 1; 1; 1 | — |
| PRIMARY Adverse Reaction Related to Sodium Fluorescein Injection |
3; 1; 15; 3; 1 | — |
| SECONDARY Surgeon Satisfaction Regarding Ureteral Efflux Visualization by Filling Out a Dedicated Questionnaire |
27; 2; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- total laparoscopic hysterectomy
Exclusion Criteria
- breastfeeding
- renal insufficiency
- Medication: Probenecid, digoxin, quinidine, beta-blocker
- hypersensitivity or intolerance to sodium fluorescein
Data sourced from ClinicalTrials.gov (NCT02971800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.