Preoperative Hypocalcaemia, a Comparative Clinical Trial (professor)

Vitamin D and Calcium Supplementation to Prevent Post-total Thyroidectomy Hypocalcaemia, a Comparative Clinical Trial

two groups of patients undergoing total thyroidectomy one group received calcium and vit d prophylaxis the other group received no prophylaxis the investigator measured calcium level post and preoperative and development of tetant was recorded

Study Overview

• Status: Completed
• Conditions: Total Thyroidectomy
• Intervention / Treatment: Dietary supplement: Vitamin D; Dietary supplement: rice starch tablets

Detailed Description

This study is randomized controlled trial carried out on 86 patients undergoing total thyroidectomy in the period between January 2018 and November 2019. Patients were randomly allocated into two groups each one 43 patients the first group is the supplementation group where patients received oral vitamin D 40000 IU and calcium tablets 1 g once before surgery.

Patient included in this study are those above 18 years old undergoing total thyroidectomy.

Patients excluded from this study are those with

• Previous thyroid surgery
• Malabsorption diseases
• Pregnancy
• Previous parathyroid disease or surgery
• Vitamin D deficiency
• Renal impairment
• Hypo or hyper calcaemia
• ASA class 3,4

all patients in this study were subjected to thorough history taking full clinical examination, body mass index calculation, proper assessment of the original thyroid disease requiring surgery, preoperative investigations done as usual in addition to serum calcium, serum magnesium, serum vitamin D and serum parathormon level.

Serum calcium and serum parathormon were tested after 6, 12 and 48 postoperative hours, patients were discharged on the third postoperative day except if further hospitalization was indicated, after discharge patients were followed up in the outpatient clinic by one of the surgical team, serum calcium and parathormon level were tested after1 months, 3 months and after 6th months.

The primary outcome of this study is the development of hypocalcaemia either clinically or laboratory.

Clinical hypocalcaemia means development of perioral and \ or acral tingling and numbness, twitches of the perioral region on tapping in front of the ear" Chvostec's sign'', muscle twitches and development of carpopedal spasm.

Laboratory hypocalcaemia means serum calcium level below 8.5 mg\dl. Secondary outcome is the postoperative parathormon level. Preoperative data, postoperative clinical follow up and laboratory data were collected and analyzed using SPSS 22 program package.

Principles of total thyroidectomy; Total thyroidectomy was performed under general anesthesia, through lower neck collar incision, skin and platysma muscle flap was raised till the thyroid cartilage, opening the midline raphe, exploration of each thyroid lobe and tracing the inferior thyroid artery while emerging from underneath the carotid artery, the inferior thyroid artery was identified with its branches supplying the parathyroid gland, which was identified and preserved with its blood supply, the recurrent laryngeal nerve was searched for in the triangle between the carotid artery , trachea and the inferior thyroid artery. The external laryngeal nerve was identified and preserved 1 cm superior to the upper thyroid pole. If radical thyroidectomy was deemed the same principles of preserving parathyroid glands and their blood supply, recurrent and external laryngeal nerves. If the surgeons ere sure of damaging or removing the parathyroid glands a half of one of them was minced and transplanted in the subcutaneous tissue of the left forearm

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sharqya
    • Zagazig, Sharqya, Egypt, 44519
      • Zagazig Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient undergoing total thyroidectomy

Exclusion Criteria:

• Previous thyroid surgery
• Malabsorption diseases
• Pregnancy
• Previous parathyroid disease or surgery
• Vitamin D deficiency
• Renal impairment
• Hypo or hyper calcaemia
• ASA class 3,4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: supplementation arm; 43 patients undergoing total thyroidectomy received 40000 IU vit D and once before operation and 500mg calcium tab 4 times in the day before surgery	Dietary supplement: Vitamin D; comparison between pre- and postoperative calcium and vitamin d level after vit d and calcium supplementation; Other Names: calcium supplementation
Active Comparator: non-supplementation arm; 43 patients undergoing total thyroidectomy received rice starch tablets /6 hrs in the day before surgery	Dietary supplement: rice starch tablets; rice starch tablets as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with hypocalcemia	calcium level below 8.5 mg\dl measured by serum calcium assay	24 hrs post operative
number of participants with hypocalcaemia	calcium level below 8.5 mg\dl measured by serum calcium assay	after 7 days post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with decreased parathormone level below normal level	level of parathormone below 10 pg/mL	( 1st month post operative)
number of participants with tetany	development of tingling, numbness or carpopedal spasm measured by clinical examination and patient history	1 week

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: hazem nour, zag university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: December 22, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (Actual): December 27, 2019

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 25, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: hypocalcaemia, thyroidectomy, vit D, calcium
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Hypocalcemia; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: hazem nour ca++

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No