Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy

• Sponsor: Aix Marseille Université (Other)
• Overall Status: Completed
• CT.gov ID: NCT04372225
• Collaborator: (none)
• Enrollment: 477
• Location: 1

Study Details

Study Description

Brief Summary

With increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia.

The aim of this study was to investigate in patients undergoing total thyroidectomy whether serum calcium and/or PTH levels can predict hypoparathyroidism.

Condition or Disease	Intervention/Treatment	Phase
Hypoparathyroidism	Other: analysis of hypocalcemia

Detailed Description

Our study consists of analyzing the calcium (mmol/l) and PTH (pmol/l) levels on the first postoperative day. Postoperative treatment with calcium and vitamin D and the length of hospital stay is also taken into consideration.

We also analyze post-operative complications.

Study Design

• Study Type: Observational
• Actual Enrollment: 477 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy: is Safe Discharge Without Supplementation Possible?
• Actual Study Start Date: Apr 25, 2020
• Actual Primary Completion Date: Apr 25, 2020
• Actual Study Completion Date: Apr 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
477 patients the biological tests of 477 patients undergoing total thyroidectomy were analyzed	Other: analysis of hypocalcemia; analysis of postoperative calcium and PTH levels

Outcome Measures

Primary Outcome Measures

1. calcium and PTH thresholds [one years]

   For all 477 patients postoperative calcium and PTH levels and treatment with calcium and vitamin D will be analyzed. Objective is to identify the calcium and PTH thresholds at which the patient after total thyroidectomy can be discharged without risk of hypocalcemia.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Total thyroidectomy

Exclusion Criteria:

• concomitant parathyroidectomy for primary hyperparathyroidism

• lobectomy only

• completion thyroidectomy

• central and lateral neck dissection

• patients with calcium and/or vitamin D supplementation prior surgery

• patients with known and significant osteoporosis and renal failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Conception Hospital	Marseille		France	13005

Sponsors and Collaborators

• Aix Marseille Université

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paladino Nunzia Cinzia, Principal Investigator, Aix Marseille Université
• ClinicalTrials.gov Identifier: NCT04372225
• Other Study ID Numbers: ArixMU
• First Posted: May 1, 2020
• Last Update Posted: May 1, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Paladino Nunzia Cinzia, Principal Investigator, Aix Marseille Université: thyroidectomy; hypocalcemia; hypoparathyroidism; discharge; PTH
• Additional relevant MeSH terms: Hypocalcemia; Hypoparathyroidism

Study Results

No Results Posted as of May 1, 2020