Transient Hypoparathyroidism
Conditions
Keywords
transient hypoparathyroidism, steroids, total thyroidectomy
Brief 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
Interventions
DRUGphosphate and betamethasone acetate, 2 mL.
single dose of intramuscular depot corticosteroid
DRUGsaline 0.9% NaCl
single dose of intramuscular placebo
Sponsors
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Hypocalcemia | 3 days | Serial postoperative blood samples will be made to detect hypocalcemia (defined as \<8,5 mg/dL) 1. at 1 hour postoperative from skin closure, 2. at 6 hours after surgery 3. 24 hours 4. 72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Related Adverse Events | 30 days | 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) |
Countries
Argentina
Contacts
Primary ContactDiego H Giunta, MD
Backup ContactJuan Achaval Rodriguez, MD
Outcome results
None listed