Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial
NCT ID: NCT05044351
Last Updated: 2023-11-09
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
170 participants
INTERVENTIONAL
2021-09-15
2023-10-16
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 centers is needed:
Aim: To investigate the impact of NIRAF on hemithyroidectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in a low-volume, non-parathyroid institution.
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Detailed Description
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(A) NIRAF-assisted hemithyroidectomy (Fluobeam LX) or (B) Conventional hemithyroidectomy. PTH and ionized calcium will assessed preoperatively, on postoperative day 1 (POD1) and one month following surgery. Parathyroid identification rates, rates of autoimplantation and inadvertently excised parathyroid glands will be assessed and compared.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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(A): NIRAF-assisted surgery
Patients undergoing NIRAF-assisted hemithyroidectomy
Fluobeam LX
See arm description
(B): Conventional surgery
Patients undergoing conventional hemithyroidectomy without NIRAF-assistance
Conventional surgery without NIRAF assistance
Patients undergoing conventional hemithyroidectomy without NIRAF-assistance
Interventions
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Fluobeam LX
See arm description
Conventional surgery without NIRAF assistance
Patients undergoing conventional hemithyroidectomy without NIRAF-assistance
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
* Age \< 18
* Unable to understand patient information
* Unable to give informed consent
18 Years
ALL
No
Sponsors
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Regional Hospital West Jutland
OTHER
Responsible Party
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Ali Abood
MD
Locations
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Department of Otorhinolaryngology, Regional Hospital West Jutland
Holstebro, , Denmark
Countries
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References
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Abood A, Rolighed L, Ovesen T, Madsen SH, Vestergaard P, Triponez F. Autofluorescence-guided hemithyroidectomy in a low-volume thyroid institution with no experience in parathyroid surgery: randomized clinical trial. Br J Surg. 2024 Apr 3;111(4):znae075. doi: 10.1093/bjs/znae075.
Other Identifiers
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Autofluorescence2.0
Identifier Type: -
Identifier Source: org_study_id
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