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Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions

NCT05043584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-01-03

No results posted yet for this study

Summary

Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown.

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.

Conditions

  • Autofluorescence
  • Thyroidectomy
  • Hypoparathyroidism
  • Hypocalcemia

Interventions

DEVICE

Fluobeam LX, Fluoptics, Grenoble, France

See arm description

Sponsors & Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • Regional Hospital West Jutland

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05043584 on ClinicalTrials.gov