NCT03777033

Brief Summary

Transient hypocalcaemia consist the most common postoperative complication after thyroidectomy (10-45%). It may be mild and subclinical or cause mild or severe symptoms and may lead to longer hospital stay as well as in discomfort of the patients. For the management oral or intravenous calcium with or without vitamin D administration can be used based on the blood calcium levels and on the symptomatology. The investigators intent to study a new protocol with oral calcium and vitamin D given systematically from the day of operation to assess if this practice can minimize the rate of transient hypocalcaemia and as a consequence minimize the length of stay in the hospital.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2020

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

5.1 years

First QC Date

October 25, 2017

Last Update Submit

September 3, 2019

Conditions

Thyroid Diseases

Outcome Measures

Primary Outcomes (3)

  • blood calcium levels (mg/dl) on the 1st postoperative day

    blood calcium measured in a blood sample in mg/dl

    From the end of the operation until 24 hours after the operation

  • blood calcium levels (mg/dl) on the 2nd postoperative day

    blood calcium measured in a blood sample in mg/dl

    From the end of the operation until 48 hours after the operation

  • Length of hospital stay in days

    how many days the patient remained in the hospital

    From the day of the operation until a week after the operation

Secondary Outcomes (1)

  • Overall cost of the treatment ( euros)

    From the day of the operation until a month from the operation

Study Arms (2)

Control Group

NO INTERVENTION

Patients after thyroidectomy will be managed as usual. Oral or IV supplements of Calcium will be giver on demand and recorded according to the clinical picture or the biochemical hypocalcaemia.

Study group

EXPERIMENTAL

Intervention: the patients will be given prophylactically ca and vit D. Patients after thyroidectomy will be given systematically from the day of operation a scheme with oral calcium in the form of 1000ca++mg/tab and oral alfacalcidol in the form of 0.5 micrograms/tb Intervention: The patients will receive one tablet three times a day oral calcium (3g/d) and 2 tablets , two times a day alfacalcidiol (2 micrograms/d) for the first 5 days. Afterwards they will be taking 2 tablets a day of oral calcium ( 2g) and 2 tablets a day alfacalcidiol (1micrograms/d) for another 10 days ( total 15 days)

Drug: Prophylactic protocol with Ca and Vit D

Interventions

Prophylactic protocol with Ca and Vit DDRUG

3g calcium /day for 5 days and then 2g/day for 10 days 2 Micrograms Alfacalcidol/day and then 1 microgram /day for 10 days the Prophylactic protocol with Ca and Vit D will be given in the form of Alfacalcidol 0.5 Micrograms Capsule and CALCIUM CARBONATE + CALCIUM GALACTOGLUCONATE 1000mg tablet

Also known as: one-alfa and mega calcium
Study group

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Thyroid pathology only
  • No calcium metabolism problems
  • Total / near total thyroidectomy

You may not qualify if:

  • Renal failure,
  • Secondary hyperparathyroidism,
  • Primary hyperparathyroidism,
  • thyroid lobectomy,
  • Thyroid reoperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital,

Athens, 11636, Greece

RECRUITING

Related Links

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Sophocles Lanitis

    Korgiallenio benakeio hellenic red cross hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SOPHOCLES LANITIS, M.D, PhD

CONTACT

00306974445355drlanitis@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized control trial - control group ( supplements of calcium and vit D on demand) vs study group ( systematic administration of oral calcium and vit D )
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, PhD, Consultant in General Surgery

Study Record Dates

First Submitted

October 25, 2017

First Posted

December 17, 2018

Study Start

March 1, 2015

Primary Completion

April 1, 2020

Study Completion

August 4, 2020

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations

GR(1)