Investigation of the use of special camera technology during thyroid surgery to avoid the need for calcium supplementation after surgery

Prospective randomized clinical trial for the evaluation of the use of autoFLUorescence technology in the prevention of postoperative hypoPARathyroidism in patients undergoing thyroidectomy with or without neck dissection

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17501072

Enrollment

400

Registered

2021-06-24

Start date

2021-06-28

Completion date

Unknown

Last updated

2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of postoperative hypoparathyroidism in patients undergoing thyroid operations Nutritional, Metabolic, Endocrine Postprocedural hypoparathyroidism

Interventions

This study will include patients undergoing total thyroidectomy, with or without neck lymph node dissection. In the first arm, the autofluorescence technique will be used for the intr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients over 18 years old undergoing total thyroidectomy with or without neck lymph node dissection

Exclusion criteria

Exclusion criteria: 1. Patients undergoing reoperation for thyroid pathology 2. Patients undergoing less than total thyroidectomy (lobectomy, hemithyroidectomy, subtotal thyroidectomy) 3. Patients who have hyperthyroidism 4. Patients who simultaneously with thyroidectomy have an operation for primary, secondary or tertiary hyperparathyroidism

Design outcomes

Primary

Measure	Time frame
1. Total calcium levels measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months 2. Albumin measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months 3. Phosphorous measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months 4. Intact parathormone levels measured using a blood test (chemiluminescence immunoassay) at baseline, 1 day, 1 week, and 6 months 5. 25-OH-Vit D measured using a blood test (chemiluminescence immunoassay) at baseline	—

Measure

Time frame

1. Total calcium levels measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months 2. Albumin measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months 3. Phosphorous measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months 4. Intact parathormone levels measured using a blood test (chemiluminescence immunoassay) at baseline, 1 day, 1 week, and 6 months 5. 25-OH-Vit D measured using a blood test (chemiluminescence immunoassay) at baseline

—

Secondary

Measure	Time frame
1. Number of parathyroid glands detected intraoperatively measured using autofluorescence or direct visualisation during the operation 2. Number of unintentional removals of parathyroid glands measured using the histopathology report at 1 month (after receiving the official report) 3. Number of autotransplantation of parathyroid glands measured using operation notes at day 1	—

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026