Improving Safety in Pediatric Thyroidectomy by PTH Measurements

Sponsor

Hospital de Niños R. Gutierrez de Buenos Aires (Other)

Overall Status

Completed

CT.gov ID

NCT04690842

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoparathyroidism Postprocedural	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 Design

Study Type:

Observational

Actual Enrollment :

66 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Apr 1, 2020

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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