Improving Safety in Pediatric Thyroidectomy by PTH Measurements

Implementation of PTH Measurement Intra / Post Thyroidectomy to Improve Post Surgical Safety in Pediatric Patients

We implemented a previously reported algorithm based on intra-postoperative PTH measurements with selected cut-off values, both to predict post-thyroidectomy hypoparathyroid hypocalcemia, and to guide postsurgical management. The objective of the study was to assess if this strategy was useful to reduce hypocalcemia, post-surgery calcium sampling and hospitalization length.

Study Overview

• Status: Completed
• Conditions: Hypoparathyroidism Postprocedural
• Intervention / Treatment: Diagnostic test: PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal)

Detailed Description

Sixty-six patients were included in the analysis. Based on their intra-operatory PTH determinations, patients were classified according to their post-surgical hypoparathyroidism risk and were either immediately treated with calcium and vitamin D1-25 supplementation (high-risk) or assigned to clinical control and routine calcium sampling (low-risk). The outcomes and overall results of these therapeutical approaches were compared with those of a control group, started on treatment when TCa levels dropped below normal.

In the high-risk subgroup (n=30) five patients showed hypocalcemia within the first 24 hours. Compared with the high-risk control subgroup, the incidence of hypocalcemia fell from 100% to 17% (p<0.001), and the median hospitalization length from 6 to 3 days (p<0.001).

In the low-risk subgroup (n=36) 28 patients remained normocalcemic with significantly less calcium sampling (p<0.001). Eight patients had hypocalcemia; 7 of them required neck dissection, which was the only risk factor related to post-surgical hypoparathyroidism (RR: 2.1 [CI 95% 1.4-3.1], P<0.001).

Compared to the control group, overall incidence of hypocalcemia was reduced by 58 %.

This approach improved patient's safety by reducing the occurrence of hypocalcemia and the length of hospitalization after thyroidectomy in pediatric patients. Preventive calcium supplementation seems to be more beneficial in patients undergoing neck dissection.

• Study Type: Observational
• Enrollment (Actual): 66

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients between 2 and 19 years of age who underwent total thyroidectomy at Hospital de Niños Ricardo Gutiérrez in Buenos Aires, Argentina between January 2014 and April 2020 were included. Exclusion criteria were patients with known hyper or hypoparathyroidism, kidney failure, and those taking medications known to affect TCa, PTH, or vitamin D levels (octreotide, oral glucocorticoids, diuretics and antiepileptics), or any other condition that could interfere with calcium metabolism.

Description

Inclusion Criteria:

• Patients who underwent total thyroidectomy between January 2014 and April 2020

Exclusion Criteria:

• Patients with known hyper or hypoparathyroidism, kidney failure, and those taking medications known to affect TCa, PTH, or vitamin D levels (octreotide, oral glucocorticoids, diuretics and antiepileptics), or any other condition that could interfere with calcium metabolism

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical hypocalcemia post thyroidectomy occurrence	total Calcium level < 8 mg/dl	48 hours postthyroidectomy
Symptomatic hypocalcemia post thyroidectomy ocurrence	Signs o symptoms of hypocalcemia (Chvostek or Trousseau signs, tingling, numbness, muscle cramps, spasms, tetany or seizures	48 hours posthyroidectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
days of hospitalization after thyroidectomy	number of days that patient need hospitalization (high risk group)	up to 15 days after thyroidectomy
number of Calcium sampling	number of venipuncture performed to control serum calcium level (low risk group)	48 hours postthyroidectomy

Collaborators and Investigators

• Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Publications and helpful links

General Publications

• Freire AV, Ropelato MG, Ballerini MG, Acha O, Bergada I, de Papendieck LG, Chiesa A. Predicting hypocalcemia after thyroidectomy in children. Surgery. 2014 Jul;156(1):130-6. doi: 10.1016/j.surg.2014.02.016. Epub 2014 Feb 27.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (ACTUAL): December 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: hypocalcemia; Thyroidectomy; PTH; Pediatric surgery
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hypoparathyroidism
• Other Study ID Numbers: CEI 19.27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No