Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia

Study Overview
=================
Brief Summary
-----------------
Hypocalcaemia after thyroidectomy is observed with increasing frequency, often resulting in prolonged hospital stay with increased use of resources, delayed return to work and reduced quality of life. The administration of vitamin D is essential in the therapy of postoperative hypocalcaemia. What has not been examined so far is whether and how routine preoperative cholecalciferol prophylaxis can help to prevent postoperative hypocalcaemia

Detailed Description
-----------------
Hypocalcemia following thyroid surgery is caused either due to parathyroid devascularization, stunning, or accidental removal of the parathyroid glandsMultiple risk factors have been identified which predispose patients to develop post-operative hypocalcemia. In light of the available evidence of prevalent vitamin D deficiency in the general population, and the observation of appearance of postthyroidectomy hypocalcemic symptoms at a much earlier stage than documented in previous literature, we postulate that a prophylactic vitamin D supplementation dose given in immediate preoperative period can significantly reduce acute symptomatic postoperative hypocalcemia in patients undergoing thyroid surgery

Official Title
-----------------
Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia : A Randomized Controlled Trial

Conditions
-----------------
Hypocalcemia

Intervention / Treatment
-----------------
* Dietary Supplement: Cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (> 18 years) Scheduled for TT Thyroid cancer treated with total thyroidectomy without lymph node dissection Exclusion Criteria: Lack of written consent Thyroid cancer treated with TT and lymph node dissection Mediastinal goiter with need for sternotomy Medication with thiazide diuretics, digitalis or lithium therapy Previous neck operations or radiation Preexisting hyperparathyroidism Chronic kidney failure.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholecalciferol group<br>patients will recieve one dose of Vitamin D 200000 IU PO at the time of admission | Dietary Supplement: Cholecalciferol<br>* Cholecalciferol is vitamin D derivative and as our population already vit D deficient so post-operative hypocalcemia can be prevented.<br>* Other names: Indrop-D;|
| No Intervention: Control<br>Patients will not recieve any vitamin D before admission | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative hypocalcemia | The primary outcomes measure of this study was postoperative hypocalcemia based on either clinical symptoms or laboratory values. | After 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholecalciferol, post-operative hypocalcemia, thyroidectomy