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

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 12, 2016
Last Update Posted Date April 5, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02652884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2016)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
Official Title  ICMJE Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Transient Hypoparathyroidism
Intervention  ICMJE
  • Drug: phosphate and betamethasone acetate, 2 mL.
    single dose of intramuscular depot corticosteroid
    Other Name: cronodose
  • Drug: saline 0.9% NaCl
    single dose of intramuscular placebo
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: Group 1
    will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation.
    Intervention: Drug: phosphate and betamethasone acetate, 2 mL.
  • Placebo Comparator: Group 2
    will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation.
    Intervention: Drug: saline 0.9% NaCl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 11, 2016)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02652884
Other Study ID Numbers  ICMJE 2627
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital Italiano de Buenos Aires
Study Sponsor  ICMJE Hospital Italiano de Buenos Aires
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juan Achaval, MD Hospital Italiano de Buenos Aires
Principal Investigator: Figari Marcelo, MD Hospital Italiano de Buenos Aires
PRS Account Hospital Italiano de Buenos Aires
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP