Clinical trial NCT04690842: Improving Safety in Pediatric Thyroidectomy by PTH Measurements
Official title: Implementation of PTH Measurement Intra / Post Thyroidectomy to Improve Post Surgical Safety in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoparathyroidism Postprocedural
Keywords: Thyroidectomy
PTH
Pediatric surgery
hypocalcemia
Lead sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemical hypocalcemia post thyroidectomy occurrence
timeFrame: 48 hours postthyroidectomy
measure: Symptomatic hypocalcemia post thyroidectomy ocurrence
timeFrame: 48 hours posthyroidectomy
Secondary outcomes:
measure: days of hospitalization after thyroidectomy
timeFrame: up to 15 days after thyroidectomy
measure: number of Calcium sampling
timeFrame: 48 hours postthyroidectomy
Other outcomes:
Locations:
Study officials:
References:
citation: 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.