COMPARISON OF THE EFFICACY BETWEEN PREOPERATIVE CALCIUM & VITAMIN D3 VERSUS CALCIUM SUPPLEMENTATION ALONE TO PREVENT POST OPERATIVE SYMPTOMATIC HYPOCALCEMIA AFTER TOTAL THYROIDECTOMY IN EUTHYROID PATIENTS
Total thyroidectomy is a commonly performed surgery for thyroid diseases such as multinodular goiter. One of the most frequent complications after this procedure is hypocalcemia (low blood calcium levels), which may cause symptoms such as tingling around the mouth, muscle cramps, and in severe cases, spasms or confusion. This condition usually occurs within the first 24-72 hours after surgery and may delay hospital discharge and increase patient discomfort.
This study aims to compare the effectiveness of preoperative calcium plus vitamin D3 supplementation versus calcium supplementation alone in preventing postoperative symptomatic hypocalcemia in patients undergoing total thyroidectomy. Patients diagnosed with multinodular goiter and planned for surgery will be randomly assigned into two groups. One group will receive calcium with vitamin D3 for seven days before surgery, while the other group will receive calcium alone for the same duration.
After surgery, patients will be monitored for symptoms of hypocalcemia and their serum calcium levels will be checked at 6, 24, and 48 hours, as well as at a follow-up visit on day 14. The main outcome of the study is the occurrence of symptomatic hypocalcemia in both groups.
The results of this study may help determine whether adding vitamin D3 to preoperative calcium supplementation provides better protection against hypocalcemia after thyroid surgery, potentially improving patient outcomes and reducing hospital stay.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Total thyroidectomy is a standard surgical procedure performed for benign and malignant thyroid disorders, particularly multinodular goiter. Despite being a safe operation, one of its most common and clinically significant complications is postoperative hypocalcemia, which primarily results from transient or permanent impairment of parathyroid gland function due to devascularization, inadvertent removal, or surgical trauma. Symptomatic hypocalcemia typically occurs within 24-72 hours after surgery and may present with neuromuscular irritability such as perioral numbness, paresthesia, muscle cramps, carpopedal spasm, tetany, or, in severe cases, cardiac arrhythmias. This complication can lead to prolonged hospital stay, increased patient morbidity, and higher healthcare costs.
Various strategies have been proposed to reduce the incidence and severity of post-thyroidectomy hypocalcemia, including routine postoperative calcium supplementation, selective supplementation based on serum calcium or parathyroid hormone levels, and preoperative administration of calcium and vitamin D3. Vitamin D3 plays a key role in calcium homeostasis by enhancing intestinal calcium absorption and improving postoperative calcium balance, potentially reducing the risk of symptomatic hypocalcemia when administered preoperatively along with calcium.
This randomized controlled trial is designed to compare the efficacy of preoperative calcium plus vitamin D3 supplementation versus calcium supplementation alone in preventing postoperative symptomatic hypocalcemia in euthyroid patients undergoing total thyroidectomy for multinodular goiter. Eligible patients will be randomized into two groups: one receiving oral calcium with vitamin D3 and the other receiving oral calcium alone for seven days prior to surgery.
Postoperatively, patients will be closely monitored clinically and biochemically. Serum corrected calcium levels will be measured at 6, 24, and 48 hours after surgery, and again at a 14-day follow-up visit. Parathyroid hormone levels will also be assessed at selected time points. Symptomatic hypocalcemia will be defined based on the presence of clinical features in combination with low serum calcium levels.
The study aims to determine whether preoperative vitamin D3 supplementation provides additional benefit over calcium alone in reducing the incidence of postoperative symptomatic hypocalcemia, thereby improving early postoperative recovery, reducing hospital stay, and optimizing perioperative management in thyroid surgery patients.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Ali Raza, MBBS
- Telefonnummer: +923406600052
- E-Mail: dralirazasial777@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Ahmad Rauf, MBBS
- Telefonnummer: +923006023465
- E-Mail: ahmadrauf498@gmail.com
Studienorte
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- King Edward Medical University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- A) Age between 18 to 60 years B) Both genders C) Multiple nodular goiter diagnosed on the basis of history and investigation like thyroid function test , USG neck for TIRADS scoring and USG guided FNAC to confirm the diagnosis .
D) ASA grade 1 &2 E) With preserved one or two parathyroid gland
Exclusion Criteria:
- A) Cardiovascular disease B) Deranged Renal parameters C) Pregnancy D) Concomitant endocrine pathology warranting the surgery
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Preoperative Calcium and Vitamin D3 Supplementation
Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) along with oral vitamin D3 (cholecalciferol 1000-2000 IU once daily) for 7 days prior to total thyroidectomy.
This supplementation is given to assess its effectiveness in reducing postoperative symptomatic hypocalcemia compared to calcium alone.
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Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) in combination with oral vitamin D3 (cholecalciferol 1000-2000 IU once daily) for 7 days prior to total thyroidectomy.
This preoperative supplementation is administered to evaluate its effectiveness in reducing the incidence of postoperative symptomatic hypocalcemia.
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Aktiver Komparator: Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily)
Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) for 7 days prior to total thyroidectomy without vitamin D3 supplementation.
This group serves as the control to compare the incidence of postoperative symptomatic hypocalcemia.
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Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) in combination with oral vitamin D3 (cholecalciferol 1000-2000 IU once daily) for 7 days prior to total thyroidectomy.
This preoperative supplementation is administered to evaluate its effectiveness in reducing the incidence of postoperative symptomatic hypocalcemia.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Incidence of postoperative symptomatic hypocalcemia
Zeitfenster: 3 month
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3 month
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Ahmad Rauf, MBBS, KEMU
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Dr Ali Raza
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Studiendaten/Dokumente
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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