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A study to compare the rates of decreased calcium levels in blood after total thyroid removal operation when using Indocyanine green dye v/s no dye usage

Completed
Registration Number
CTRI/2018/07/015095
Lead Sponsor
All India Institute of Medical Sciences New Delhi
Brief Summary

Identification of parathyroid glands is one of the main concerns in thyroid surgery. It is usually very difficult to distinguish parathyroid glands from thyroid and surrounding tissues in the neck due to their small size and variable location. The percentage of incidental parathyroidectomies is around 16% The incidence rate of hypocalcemia can reach up to 4.5% in total thyroidectomies rising to 11.5% in thyroidectomies with central node dissection. These rates can increase to 50% for transient hypocalcemia and 13.8% for permanent hypocalcemia in total thyroidectomies. The main cause of hypocalcaemia after total thyroidectomy is hypoparathyroidism due to intraoperative damage to the parathyroid glands by trauma, inadvertent parathyroid gland removal or devascularization. The extent of damage to the parathyroid glands is difficult to predict during surgery. The feasibility of ICG in assessing the parathyroid gland function in patients undergoing thyroidectomy and thereby preventing postoperative hypocalcemia is being compared with our conventional methods in this study

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
20
Inclusion Criteria

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

Exclusion Criteria
  • 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
NameTimeMethod
2. To compare the incidence of postoperative hypocalcemia after ICG guided assessment of parathyroid function with that of conventional methodsPostoperative Day 0 and postoperative day 1
1. To evaluate the use of ICG angiography to assess parathyroid gland function after thyroid surgery and thereby, take appropriate steps to prevent postoperative hypocalcemiaPostoperative Day 0 and postoperative day 1
Secondary Outcome Measures
NameTimeMethod
To find the correlation between parathyroid fluorescence after ICG dye injection and POD0 and POD1 calcium levels and POD1 PTH levelsPostoperative day 0 and postoperative day 1

Trial Locations

Locations (1)

All India Institute of Medical Sciences, New Delhi

🇮🇳

Delhi, DELHI, India

All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Keshav Agarwal
Principal investigator
9818442016
keshavagar@gmail.com

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