The Impact of Vitamin D Deficiency on Hypocalcaemia Following Total Thyroidectomy

NCT03063060 | Unknown

• 1 other identifier: 0014-17
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-operative hypocalcaemia following total thyroidectomy is a well-known complication and becoming a major area of research. Many factors are assumed to increase the incidence of post-thyroidectomy hypocalcaemia, but the impact of vitamin D deficiency remains uncertain. Since results so far were inconclusive, the goal in this study is to significantly determine the relation between those two factors. This study is the first to deal with this issue through patients who underwent total thyroidectomy that was performed by the same surgeon and the same surgical technique. A retrospective evaluation study of patients who underwent total thyroidectomy at the head and neck unit of the Otorhinolaryngology department at our institution between January 2013 and October 2016. A total number of 60 patients underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels. Pre-operative vitamin D and PTH levels were checked within a maximum of one month duration before surgery. All patients were operated by the same surgeon -Dr. Galit Avior-, with the same surgical technique. The study involves access to the patients files and admission reports. In addition the investigators would like to be able to call the patients in order to ask them whether Vitamin D deficiency was corrected or not before their surgery, and If it was corrected then when exactly.

Conditions

Hypocalcemia; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (3)

• Vitamin D levels

  ng/ml

  pre- operative vitamin D levels 1 month prior to surgery

• Calcium levels

  mg/dl

  post operative Ca levels at the day of the surgery

• Calcium levels

  mg/dl

  post operative Ca levels 1 day after the surgery

Study Arms (1)

total thyroidectomy

patients who underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels.

Other: vitamin D levels and Calcium levels examination

Interventions

vitamin D levels and Calcium levels examination OTHER

observational

total thyroidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total number of 60 patients underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels. Pre-operative vitamin D and PTH levels were checked within a maximum of one month duration before surgery.

You may qualify if:

• Adult patients ≥ 18 years.
• Both males and females.
• Patients who underwent total thyroidectomy.
• Documented 25-hydroxyvitamin D level preoperatively.
• Documented calcium levels pre and postoperatively.
• Documented PTH levels pre and postoperatively.

You may not qualify if:

• Patients with either hypocalcaemia or hypercalcemia before surgery.
• Patients with Grave's disease.
• Patients with renal, lung or bone cancer.
• Pregnancy.

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

MeSH Terms

Conditions

Hypocalcemia; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of ethics board

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 24, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 24, 2017

Record last verified: 2017-02