Preoperative Hypocalcaemia, a Comparative Clinical Trial (professor)
Primary Purpose
Total Thyroidectomy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
rice starch tablets
Sponsored by
About this trial
This is an interventional prevention trial for Total Thyroidectomy focused on measuring hypocalcaemia, thyroidectomy, vit D, calcium
Eligibility Criteria
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
Sites / Locations
- Zagazig Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
supplementation arm
non-supplementation arm
Arm Description
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
43 patients undergoing total thyroidectomy received rice starch tablets /6 hrs in the day before surgery
Outcomes
Primary Outcome Measures
number of participants with hypocalcemia
calcium level below 8.5 mg\dl measured by serum calcium assay
number of participants with hypocalcaemia
calcium level below 8.5 mg\dl measured by serum calcium assay
Secondary Outcome Measures
number of participants with decreased parathormone level below normal level
level of parathormone below 10 pg/mL
number of participants with tetany
development of tingling, numbness or carpopedal spasm measured by clinical examination and patient history
Full Information
NCT ID
NCT04212533
First Posted
December 22, 2019
Last Updated
December 25, 2019
Sponsor
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT04212533
Brief Title
Preoperative Hypocalcaemia, a Comparative Clinical Trial
Acronym
professor
Official Title
Vitamin D and Calcium Supplementation to Prevent Post-total Thyroidectomy Hypocalcaemia, a Comparative Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Thyroidectomy
Keywords
hypocalcaemia, thyroidectomy, vit D, calcium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two parallel groups each one 43 patients undergoing total thyroidectomy one received prophylactic vitamin d and calcium before surgery the other received nothing , calcium level, vit d levels measured preand postoperative , clinical assessment of patients postoperatie for development of tetany
Masking
Participant
Masking Description
the patients dont know what they received before the operation
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
supplementation arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
non-supplementation arm
Arm Type
Active Comparator
Arm Description
43 patients undergoing total thyroidectomy received rice starch tablets /6 hrs in the day before surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
calcium supplementation
Intervention Description
comparison between pre- and postoperative calcium and vitamin d level after vit d and calcium supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
rice starch tablets
Intervention Description
rice starch tablets as placebo
Primary Outcome Measure Information:
Title
number of participants with hypocalcemia
Description
calcium level below 8.5 mg\dl measured by serum calcium assay
Time Frame
24 hrs post operative
Title
number of participants with hypocalcaemia
Description
calcium level below 8.5 mg\dl measured by serum calcium assay
Time Frame
after 7 days post operative
Secondary Outcome Measure Information:
Title
number of participants with decreased parathormone level below normal level
Description
level of parathormone below 10 pg/mL
Time Frame
( 1st month post operative)
Title
number of participants with tetany
Description
development of tingling, numbness or carpopedal spasm measured by clinical examination and patient history
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hazem nour
Organizational Affiliation
zag university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig Faculty of Medicine
City
Zagazig
State/Province
Sharqya
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Preoperative Hypocalcaemia, a Comparative Clinical Trial
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