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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02971800 |
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Date of registration:
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15/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Sodium Fluorescein Use During Intraoperative Cystoscopy After Total Laparoscopic Hysterectomy
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Scientific title:
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Evaluation of Sodium Fluorescein Use During Intraoperative Cystoscopy After Total Laparoscopic Hysterectomy |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02971800 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Philippe Y Laberge, doctorate |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Quebec |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- total laparoscopic hysterectomy
Exclusion Criteria:
- breastfeeding
- renal insufficiency
- Medication: Probenecid, digoxin, quinidine
- hypersensitivity or intolerance to sodium fluorescein
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ureteral Injury
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Intervention(s)
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Drug: sodium fluorescein injection 10%
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Primary Outcome(s)
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Adverse reaction related to sodium fluorescein injection
[Time Frame: From sodium fluorescein injection to follow-up 2 months after surgery]
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Quality of ureteral efflux coloration with sodium fluorescein collected with dedicated questionnaire
[Time Frame: within 15 minutes after the beginning of cystoscopy]
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Secondary Outcome(s)
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Surgeon satisfaction regarding ureteral efflux visualization by filling out a dedicated questionnaire
[Time Frame: after cystoscopy (up to 15 min after injection)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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