Transient Hypoparathyroidism Clinical Trial
— CorthyroidOfficial title:
Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
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.
| Status | Recruiting |
| Enrollment | 110 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - adult - thyroidectomy postoperative - prepaid affiliate patients Exclusion Criteria: - allergy - CKD - idiophatic thrombocytopenic purpura - hyperthyroidism - chronic use of corticoids - no follicular cancer, nonpapillary - refusal to participate |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Italiano de Buenos Aires | Ciudad Autonoma de Buenos Aires |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Italiano de Buenos Aires |
Argentina,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postoperative Hypocalcemia | Serial postoperative blood samples will be made to detect hypocalcemia (defined as <8,5 mg/dL) at 1 hour postoperative from skin closure, at 6 hours after surgery 24 hours 72 hours |
3 days | Yes |
| Secondary | Related Adverse Events | Any negative effects of corticosteroids will be also recorded in the postoperative and during 30 days follow up after surgery. Major side effects associated with glucocorticoid therapy are: Gastrointestinal (Gastritis, Peptic ulcer disease, Pancreatitis, Steatohepatitis, Visceral perforation) Dermatologic and soft tissue (Skin thinning and purpura) Cardiovascular (Arrhythmias, Hypertension, Hypotension) |
30 days | Yes |