Status:
RECRUITING
Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation
Lead Sponsor:
Hôpital NOVO
Conditions:
Hypocalcemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy
Detailed Description
Thyroidectomy is a frequent procedure. This surgery is well known but not devoid of risks. The most common postoperative complication is transitory hypocalcemia. Some studies have reported that preope...
Eligibility Criteria
Inclusion
- Patient ≥ 18 years old
- Patient shall be operated on for a total thyroidectomy in one time for any indication
- Written informed consent (IC) obtained
- Patients with affiliation to the social security system
Exclusion
- • Medical history of : Thyroid or parathyroid surgery Hyperparathyroidism Granulomatosis flare-up
- Hypocalcemia, hypercalcemia/ hypercalciuria, or symptom of Hypocalcemia, hypercalcemia/ hypercalciuria, not due to thyroid pathologies
- Chronic kidney disease grade ≥4
- Severe liver failure
- 25OHD supplementation within last 3 months before surgery
- Malabsorption syndrome
- Known hypersensitivity to vitamin D
- Medical history of calcic lithiasis
- Pregnant women
- Vulnerable populations (guardianship or trusteeship)
- Allergies to one of the components of the fruit juice
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04775381
Start Date
June 30 2021
End Date
March 1 2026
Last Update
January 20 2025
Active Locations (6)
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1
Department of General, Digestive and Endocrine Surgery
Auxerre, France, 89000
2
Department of ENT and maxillofacial surgery
Corbeil-Essonnes, France, 91100
3
Department of Head and Neck Surgery and ENT
La Roche-sur-Yon, France, 85000
4
Hospital Lariboisière, Paris X
Paris, France, 75010