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Study of Usefulness of Fluorescence in Thiroid Surgery (ECA_SPAFLUO)

F

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status

Enrolling

Conditions

Thyroid Surgery

Treatments

Procedure: Fluorescence in thyroid surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06011369
IMIB-SPAFLUO

Details and patient eligibility

About

In thyroid surgery, the identification and preservation of the parathyroid glands and their vascularization is essential to avoid postoperative hypoparathyroidism. In this sense, fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical complication. This study aims to determine the advantages offered by fluorescence in thyroid surgery, taking into account various clinical variables.

For this, a randomized study is proposed in patients undergoing thyroid surgery with and without cervical fluorescence.

Enrollment

260 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Total thyroidectomy with/without lymph node dissection
  • Signature of informed consent

Exclusion criteria

  • Patients under 18 years of age
  • Hemithyroidectomy
  • Reintervention of thyroid surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

260 participants in 2 patient groups

Fluorescence in thyroid surgery
Experimental group
Description:
Patients undergoing thyroid surgery with cervical fluorescence.
Treatment:
Procedure: Fluorescence in thyroid surgery
No Fluorescence in thyroid surgery
No Intervention group
Description:
patients undergoing thyroid surgery without cervical fluorescence.

Trial contacts and locations

1

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Central trial contact

Beatriz Febrero, MD

Data sourced from clinicaltrials.gov

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