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Improving Safety in Pediatric Thyroidectomy by PTH Measurements

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04690842
Enrollment
66
Registered
2020-12-31
Start date
2014-06-30
Completion date
2020-04-30
Last updated
2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoparathyroidism Postprocedural

Keywords

Thyroidectomy, PTH, Pediatric surgery, hypocalcemia

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.

Interventions

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

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.

Sponsors

Hospital de Niños R. Gutierrez de Buenos Aires
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 19 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biochemical hypocalcemia post thyroidectomy occurrence48 hours postthyroidectomytotal Calcium level \< 8 mg/dl
Symptomatic hypocalcemia post thyroidectomy ocurrence48 hours posthyroidectomySigns o symptoms of hypocalcemia (Chvostek or Trousseau signs, tingling, numbness, muscle cramps, spasms, tetany or seizures

Secondary

MeasureTime frameDescription
number of Calcium sampling48 hours postthyroidectomynumber of venipuncture performed to control serum calcium level (low risk group)
days of hospitalization after thyroidectomyup to 15 days after thyroidectomynumber of days that patient need hospitalization (high risk group)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026