The role of selective versus routine parathyroid auto transplantation during total thyroidectomy in reducing rate of permanent hypoparathyroidism
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Christian medical college Vellore
- Enrollment
- 580
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of type of parathyroid auto transplantation in reducing the
Overview
Brief Summary
Thyroidectomy, though a common procedure performed world over, can result in life changing
complications such as post-operative hypoparathyroidism and recurrent laryngeal nerve palsy.
Post-operative hypoparathyroidism is the most commonly encountered complication and is
defined as a low (below the lower limit of the labs reference range) intact PTH (parathormone)
level, following bilateral thyroid surgery.
This may be either temporary when it resolves within six months of surgery or permanent when
PTH levels persist to be low six months after surgery. The reported incidence of temporary and
permanent hypoparathyroidism is 18-39% and 0-3% respectively. The reasons for the
development of post-thyroidectomy hypoparathyroidism are multifactorial, however, the most
important cause is related to the parathyroid glands and may result from either inadvertent
injury/resection to the parathyroid gland during thyroidectomy or due to devascularization of
parathyroid glands.
The management of temporary hypoparathyroidism include oral calcium and activated vitamin
D supplementation and intravenous calcium infusion in a subset of patients. This results in
increased hospital stay and cost. Further, there is a risk of re-admissions for the management of
severe hypoparathyroidism. Permanent hypoparathyroidism on the other hand, even though less
frequent, significantly impairs quality of life. In addition, long term effects include chronic renal impairment, reduced bone remodeling, increased psychiatric complaints and basal ganglia
calcification.
Various adjuncts to aid identification and the assessment of viability of the parathyroid glands
during thyroid surgery, in order to decrease the rates of post-surgery hypoparathyroidism, have
been developed. These include parathyroid angiography with indocyanine green, parathyroid
auto fluorescence, carbon nanoparticles and gamma probe. Though these methods have
reported some benefit in decreasing temporary hypoparathyroidism rates, its effects on
permanent hypoparathyroidism have not been promising. In addition, these methods are time
consuming and expensive. A simple, inexpensive, easy alternative to the above is parathyroid
gland auto-transplantation. This involves the reimplantation of at least one parathyroid gland
during thyroid surgery into the sternocleidomastoid muscle. Reimplanted parathyroid glands
have been shown to regain function in 6-8 weeks following transplant. There are two methods
of parathyroid auto-transplantation: routine and selective. We aim to compare these two
methods to determine if there is a significant
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients admitted for a total thyroidectomy with or without a neck dissection and patients undergoing completion thyroidectomy.
Exclusion Criteria
- •Patients undergoing hemi thyroidectomy.
Outcomes
Primary Outcomes
To assess the efficacy of type of parathyroid auto transplantation in reducing the
Time Frame: 6 months
rate of post-thyroidectomy permanent hypoparathyroidism at 6 months.
Time Frame: 6 months
Secondary Outcomes
- a) To analyze the incidence of permanent hypoparathyroidism at 6 months.(b) To compare the rates of post operative temporary)
Investigators
Swarna Azaria
Christian medical college, Vellore