Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions
NCT ID: NCT05043584
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2021-09-15
2023-12-01
Brief Summary
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In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid institutions is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on immediate, transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid institutions.
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Detailed Description
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PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and minimum two months following surgery. Patients who still fulfill the criteria for hypoparathyroidism at that point will be followed until one year following surgery. The rates of immediate, transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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(A): NIRAF-assisted surgery
Patients undergoing NIRAF-assisted total thyroidectomy
Fluobeam LX, Fluoptics, Grenoble, France
See arm description
Interventions
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Fluobeam LX, Fluoptics, Grenoble, France
See arm description
Eligibility Criteria
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Inclusion Criteria
* Age \> 18
* Able to understand patient information
* Able to give informed consent
Exclusion Criteria
* Need for accelerated surgery
* Insufficient biochemical profile
18 Years
ALL
No
Sponsors
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Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Regional Hospital West Jutland
OTHER
Responsible Party
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Ali Abood
Principal Investigator
Locations
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Department of Otorhinolaryngology, Hospital South West Jutland
Esbjerg, , Denmark
Department of Otorhinolaryngology, Regional Hospital West Jutland
Holstebro, , Denmark
Countries
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Other Identifiers
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Autofluorescence1.0
Identifier Type: -
Identifier Source: org_study_id
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