Improving Safety in Pediatric Thyroidectomy by PTH Measurements

NCT ID: NCT04690842

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2020-04-30

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.

Conditions

Hypoparathyroidism Postprocedural

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

PTH 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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Niños R. Gutierrez de Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

Analía Freire

Pediatric Endocrinology, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 24929763 (View on PubMed)

Other Identifiers

CEI 19.27

Identifier Type: -

Identifier Source: org_study_id