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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
Information provided by (Responsible Party):
Hospital Italiano de Buenos Aires

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.

Condition or disease Intervention/treatment Phase
Transient Hypoparathyroidism Drug: phosphate and betamethasone acetate, 2 mL. Drug: saline 0.9% NaCl Phase 4

Detailed Description:
Triple-blind randomized clinical trial

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Postoperative Hypocalcemia [ Time Frame: 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 Outcome Measures :
  1. 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)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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

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Contact: Diego H Giunta, MD diego.giunta@hospitalitaliano.org.ar
Contact: Juan Achaval Rodriguez, MD juan.achaval@hospitalitaliano.org.ar

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Hospital Italiano de Buenos Aires Recruiting
Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
Contact: Diego Giunta, MD    (05411)49590200 ext 4419    diego.giunta@hospitalitaliano.org.ar   
Principal Investigator: Diego Giunta, MD         
Principal Investigator: Veronica Gonzalez, BA         
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
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Principal Investigator: Juan Achaval, MD Hospital Italiano de Buenos Aires
Principal Investigator: Figari Marcelo, MD Hospital Italiano de Buenos Aires
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Responsible Party: Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02652884    
Other Study ID Numbers: 2627
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital Italiano de Buenos Aires:
transient hypoparathyroidism
total thyroidectomy
Additional relevant MeSH terms:
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Parathyroid Diseases
Endocrine System Diseases
Betamethasone acetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents