Total number of patients undergoing total thyroidectomy evaluated for postoperative and long term decrease of calcium levels by using intraoperative assessment of parathyroid function with indocyanine green fluoroscence compared with other group assessed by conventional method

Phase 2

Active, not recruiting

Conditions: Disorders of thyroid gland, (2) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland,

Registration Number: CTRI/2021/01/030712

Lead Sponsor: AIIMS New Delhi

Brief Summary: Identification of parathyroidglands is one of the main concerns in thyroid surgery. It is usually verydifficult to distinguish parathyroid glands from thyroid and surroundingtissues in the neck due to their small size and variable location. Thepercentage of incidental parathyroidectomies is around 16% The incidence rateof hypocalcemia can reach up to 4.5% in total thyroidectomies rising to 11.5%in thyroidectomies with central node dissection. These rates can increase to50% for transient hypocalcemia and 13.8% for permanent hypocalcemia in totalthyroidectomies. The main cause of hypocalcaemia after total thyroidectomy ishypoparathyroidism due to intraoperative damage to the parathyroid glands bytrauma, inadvertent parathyroid gland removal or devascularization. The extentof damage to the parathyroid glands is difficult to predict during surgery. Thefeasibility of ICG in assessing the parathyroid gland function in patientsundergoing thyroidectomy and thereby preventing postoperative hypocalcemia isbeing compared with our conventional methods in this study

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 56

Inclusion Criteria

All Patients undergoing total thyroidectomy for both benign and malignant conditions.

Exclusion Criteria

1.Patients with known renal impairment or iodine allergy 2.Patients with concomitant hyperparathyroidism 3.Age< 18 years Age > 70 years 4.Pregnancy 5.Patients undergoing central compartment neck dissection or modified radical neck dissection.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Parathyroid function and resultant post operative and long term Hypocalcemia in Indocyanine Green Fluorescence Guided V/S Conventional Assessment of Parathyroid Function Following Total Thyroidectomy	Post operative Day 1, 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
Treatment for Hypocalcemia in patients undergoing Total Thyroidectomy	Post operative Day 1, 3 months and 6 months

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr Abhishek Kumar Mallik
Principal investigator
9971577854
aviseq@live.com