NCT04372225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
477

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 25, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

Same day

First QC Date

April 25, 2020

Last Update Submit

April 30, 2020

Conditions

Keywords

thyroidectomyhypocalcemiahypoparathyroidismdischargePTH

Outcome Measures

Primary Outcomes (1)

  • calcium and PTH thresholds

    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.

    one years

Study Arms (1)

477 patients

the biological tests of 477 patients undergoing total thyroidectomy were analyzed

Other: analysis of hypocalcemia

Interventions

analysis of postoperative calcium and PTH levels

477 patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Analysis of calcium and PTH levels in postoperative day 1

You may qualify if:

  • Total thyroidectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Conception Hospital

Marseille, 13005, France

Location

Related Publications (1)

  • Paladino NC, Guerin C, Graziani J, Morange I, Loundou A, Taieb D, Sebag F. Predicting risk factors of postoperative hypocalcemia after total thyroidectomy: is safe discharge without supplementation possible? A large cohort study. Langenbecks Arch Surg. 2021 Nov;406(7):2425-2431. doi: 10.1007/s00423-021-02237-2. Epub 2021 Aug 10.

MeSH Terms

Conditions

HypoparathyroidismHypocalcemia

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2020

First Posted

May 1, 2020

Study Start

April 25, 2020

Primary Completion

April 25, 2020

Study Completion

April 25, 2020

Last Updated

May 1, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

the data are confidential

Locations