Postoperative Complications Clinical Trial
Official title:
Early Postoperative Serum Parathyroid Hormone Levels as a Predictor of Hypocalcaemia After Total Thyroidectomy: A Prospective Non-Randomized Study
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - The patients were eligible if they underwent total thyroidectomy regardless of the surgical indication, if complete serum PTH and calcium data were available through the first five postoperative days and if they signed an informed consent form. Exclusion Criteria: - Patients with incomplete data, preoperative pathological calcium or PTH levels, or suffering from conditions affecting calcium metabolism and parathyroid function were excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Center Sestre milosrdnice | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University Hospital "Sestre Milosrdnice" |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cut-off PTH post-thyroidectomy value | Statistically significant correlation between postoperative PTH and serum calcium values | 5 days | |
Secondary | Administration of postoperative calcium supplement therapy | Whether or not, and the amount of postoperative calcium supplement therapy needed in case of hypocalcemia | 5 days |
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