Preoperative Hypocalcaemia, a Comparative Clinical Trial
NCT ID: NCT04212533
Last Updated: 2019-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2018-01-01
2019-12-15
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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
Vitamin D
comparison between pre- and postoperative calcium and vitamin d level after vit d and calcium supplementation
non-supplementation arm
43 patients undergoing total thyroidectomy received rice starch tablets /6 hrs in the day before surgery
rice starch tablets
rice starch tablets as placebo
Interventions
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Vitamin D
comparison between pre- and postoperative calcium and vitamin d level after vit d and calcium supplementation
rice starch tablets
rice starch tablets as placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Malabsorption diseases
* Pregnancy
* Previous parathyroid disease or surgery
* Vitamin D deficiency
* Renal impairment
* Hypo or hyper calcaemia
* ASA class 3,4
18 Years
ALL
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Hazem Nour Abdellatif
Assistant professor
Principal Investigators
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hazem nour
Role: PRINCIPAL_INVESTIGATOR
zag university
Locations
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Zagazig Faculty of Medicine
Zagazig, Sharqya, Egypt
Countries
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Other Identifiers
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hazem nour ca++
Identifier Type: -
Identifier Source: org_study_id