Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy (Corthyroid)
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|ClinicalTrials.gov Identifier: NCT02652884|
Recruitment Status : Unknown
Verified January 2016 by Hospital Italiano de Buenos Aires.
Recruitment status was: Recruiting
First Posted : January 12, 2016
Last Update Posted : April 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Transient Hypoparathyroidism||Drug: phosphate and betamethasone acetate, 2 mL. Drug: saline 0.9% NaCl||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
Experimental: Group 1
will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation.
Drug: phosphate and betamethasone acetate, 2 mL.
single dose of intramuscular depot corticosteroid
Other Name: cronodose
Placebo Comparator: Group 2
will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation.
Drug: saline 0.9% NaCl
single dose of intramuscular placebo
Other Name: placebo
- Postoperative Hypocalcemia [ Time Frame: 3 days ]
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
- Related Adverse Events [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652884
|Contact: Diego H Giunta, MDfirstname.lastname@example.org|
|Contact: Juan Achaval Rodriguez, MDemail@example.com|
|Hospital Italiano de Buenos Aires||Recruiting|
|Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH|
|Contact: Diego Giunta, MD (05411)49590200 ext 4419 firstname.lastname@example.org|
|Principal Investigator: Diego Giunta, MD|
|Principal Investigator: Veronica Gonzalez, BA|
|Principal Investigator:||Juan Achaval, MD||Hospital Italiano de Buenos Aires|
|Principal Investigator:||Figari Marcelo, MD||Hospital Italiano de Buenos Aires|