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Study of post-total thyroidectomy hypocalcemia after preoperative cholecalciferol supplementation.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516793-30-00
Acronym
CHRD2115
Enrollment
200
Registered
2024-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroidectomy is a common operation. Transient postoperative hypocalcemia is the main complication, resulting in clinical discomfort for patients, longer hospital stays and increased perioperative cost. Cholecalciferol is used to supplement vitamin D deficiency. We suppose that systematic pre-operative supplementation with cholecalciferol would allow a faster and more appropriate response to post-operative hypocalcemia

Brief summary

Measure of the occurrence of serum and / or clinical hypocalcemia Serum hypocalcemia is defined by a level of calcemia, corrected for albuminemia, of less than 2.00 mmol / L. Clinical hypocalcemia is defined by the appearance of one of the following signs: sign of Chvostek, sign of Trousseau, paresthesias of the extremities and perioral between surgery and D15

Detailed description

Duration of initial hospitalization (number of hospital days), collect of adverse events and number of readmissions, Measure of severity of hypocalcemia defined by a calcemia corrected for albuminemia of less than 1.90 mmol / L and / or the use of calcium gluconate IV in the first 15 post-operative days., Measure of duration of hypocalcemia's symptoms in the first 15 days postoperative, Vitamin D deficiency will be measured by comparing the initial value of 25OHD at the inclusion visit to the value of 25OHD of the day of the operation (D0=H0), Collect of the number of adverse events and serum calcium levels for each participant, Collect of the definitive hypocalcemia's numbers in each group, Parathyroid activity will be evaluated in both group by measuring parathormone (PTH). Hypoparathyroidism being defined by PTH < 15 ng / L.

Interventions

Sponsors

Hopital NOVO
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Measure of the occurrence of serum and / or clinical hypocalcemia Serum hypocalcemia is defined by a level of calcemia, corrected for albuminemia, of less than 2.00 mmol / L. Clinical hypocalcemia is defined by the appearance of one of the following signs: sign of Chvostek, sign of Trousseau, paresthesias of the extremities and perioral between surgery and D15

Secondary

MeasureTime frame
Duration of initial hospitalization (number of hospital days), collect of adverse events and number of readmissions, Measure of severity of hypocalcemia defined by a calcemia corrected for albuminemia of less than 1.90 mmol / L and / or the use of calcium gluconate IV in the first 15 post-operative days., Measure of duration of hypocalcemia's symptoms in the first 15 days postoperative, Vitamin D deficiency will be measured by comparing the initial value of 25OHD at the inclusion visit to the value of 25OHD of the day of the operation (D0=H0), Collect of the number of adverse events and serum calcium levels for each participant, Collect of the definitive hypocalcemia's numbers in each group, Parathyroid activity will be evaluated in both group by measuring parathormone (PTH). Hypoparathyroidism being defined by PTH < 15 ng / L.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026