NCT02652884

Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy

Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in diagnosed cases brings about an increase in the number of surgeries performed on the thyroid gland, especially total thyroidectomy (TT), given that at present is still the gold standard of treatment. Transient postoperative hypoparathyroidism (HPT) is one of the most frequent complications, with an incidence of between 10 and 46% according to different sources. HPT involves longer hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin D (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of the health system. While the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti emetic of corticosteroids in thyroid surgery, the literature available to date is discordant in the use of steroid and its interaction with the HPT making clear the need for randomized clinical trials specific to analyze these variables more accurately. As inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of HPT component, investigators decided t conduct a prospective randomized, triple-blind, in order to assess the potential benefits of the most common postoperative complication reported in TT. Our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids deposit immediately postintubation in preventing the development of transient hypoparathyroidism (PTH, serum calcium and symptoms) in patients after TT.

Detailed description

Triple-blind randomized clinical trial

Conditions

• Transient Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	phosphate and betamethasone acetate, 2 mL.	single dose of intramuscular depot corticosteroid
DRUG	saline 0.9% NaCl	single dose of intramuscular placebo

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2016-01-12
• Last updated: 2016-04-05

Locations

1 site across 1 country: Argentina