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NCT Number: NCT04690842

Improving Safety in Pediatric Thyroidectomy by PTH Measurements

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal)

Diagnostic Test

We implement an algorithm employing PTH levels post-thyroidectomy to stratify patients according to their postsurgical risk for hypoparathyroidism, and to distinctively manage them in the immediate postsurgical period. High risk patients are quickly supplemented with Calcium iv and activated 25OH vitamin D. Low risk patients are clinically controlled and calcium level were checked at 24 and 48 hs post thyroidectomy.

Primary outcomes

  1. Biochemical hypocalcemia post thyroidectomy occurrence

    Time frame: 48 hours postthyroidectomy

    total Calcium level < 8 mg/dl

  2. Symptomatic hypocalcemia post thyroidectomy ocurrence

    Time frame: 48 hours posthyroidectomy

    Signs o symptoms of hypocalcemia (Chvostek or Trousseau signs, tingling, numbness, muscle cramps, spasms, tetany or seizures

Secondary outcomes

  1. days of hospitalization after thyroidectomy

    Time frame: up to 15 days after thyroidectomy

    number of days that patient need hospitalization (high risk group)

  2. number of Calcium sampling

    Time frame: 48 hours postthyroidectomy

    number of venipuncture performed to control serum calcium level (low risk group)

Sponsors and collaborators

Lead sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 31, 2020
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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