MedTrace Logo

Is There Benefit From Early Postoperative PTH Monitoring?

NCT04160637 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2019-11-14

No results posted yet for this study

Summary

This study is designed as a prospective non-randomized longitudinal single-center cohort study. It will enroll around 120 patients undergoing total thyroidectomy with data being collected from September 2019 up to December 2019. The hypothesis is that a significant association and cut-off point in PTH levels may be established with regard to postoperativne hypocalcaemia.

Primary outcome measures are presence of hypocalcemia on the first and fifth postoperative day. Secondary outcome measures are the need for calcium supplement therapy during the first five postoperative days and amount of medication given.

Associations between variables will be assessed using Spearman's rho rank correlation coefficient, the Kruskal-Wallis test for independent samples and a logistic regression model to test statistically significant correlations between PTH and serum calcium values as a primary end point.

Conditions

  • Hypocalcemia
  • Thyroid
  • Postoperative Complications
  • Parathyroid Dysfunction
  • Hormone Disturbance

Interventions

DIAGNOSTIC_TEST

Immediate postoperative PTH serum sampling and cut-off value identification

The patients will undergo immediate post-thyroidectomy PTH sampling in order to establish a cut-off value for identifying patients at risk for postoperative hypocalcemia within the first 5 postoperative days.

Sponsors & Collaborators

  • University Hospital Sestre Milosrdnice

    lead OTHER

Principal Investigators

  • Ivan Rašić, MD, PhD · Department of Otorhinolaryngology and Head and Neck Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2019-12-01
Completion
2019-12-31

Countries

  • Croatia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04160637 on ClinicalTrials.gov