Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy (Corthyroid)

April 4, 2016 updated by: Hospital Italiano de Buenos Aires

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Triple-blind randomized clinical trial

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
        • Principal Investigator:
          • Diego Giunta, MD
        • Principal Investigator:
          • Veronica Gonzalez, BA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: Juan Achaval, MD, Hospital Italiano de Buenos Aires
  • Principal Investigator: Figari Marcelo, MD, Hospital Italiano de Buenos Aires

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 12, 2016

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2627

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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