Higher Levothyroxine Requirements After Right-side Hemithyroidectomy

November 28, 2020 updated by: Carola Deischinger, Medical University of Vienna

Higher Post-operative Levothyroxine Substitution Dose Needed in Right Compared to Left Lobe Hemithyroidectomy - a Retrospective Cohort Study

459 adult patients who received a hemithyroidectomy at the Department of General Surgery, Division of Endocrine Surgery and a follow-up visit (3-12 months post-surgery) at the thyroid outpatient clinic of the Department of Endocrinology and Metabolism, Medical University of Vienna between 1994 and 2018 were identified and investigated in this retrospective study. The aim of this study was to investigate whether patients post right side hemithyroidectomy require a higher mean levothyroxine dosage than patients after left lobe hemithyroidectomy as the right thyroid lobe is bigger than the left lobe. Further, we aimed at developing a better post-surgery thyroid dosage prediction model.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In most patients, the right lobe of the thyroid gland is larger than the left lobe. After a hemithyroidectomy, the remaining lobe grows by up to 30% to compensate for the loss. However, thyroxine replacement is still necessary for 22% to 60% of all patients. The aim of this study is to investigate whether a right-lobe hemithyroidectomy predisposes to a higher postoperative dose of levothyroxine.

Patients and Methods In a retrospective cohort study, 459 patients over the age of 18 years who underwent a hemithyroidectomy at the Department of General Surgery, Division of Endocrine Surgery and a follow-up (3-12 months post-surgery) visit at the thyroid outpatient clinic of the Department of Endocrinology and Metabolism between 1994 and 2018 were investigated. The study was approved by the local ethics committee and performed in accordance with the Declaration of Helsinki. The work has been reported in line with the STROCSS criteria. The patients were identified via data extraction from a university hospital-wide Research, Documentation and Analysis (RDA) database. In a second step, further information necessary for the analysis (ultrasound data on pre-surgery thyroid volume, pre-surgery TSH, side and date of hemithyroidectomy, surgery protocol, underlying thyroid disease, type and dosage of treatment, age, weight, height, thyrotropin (TSH), free T4 (fT4), free T3 (fT3)) were extracted from the internal electronic health record system. Patients who had either received radiation therapy had undergone previous thyroid surgery, surgery on the contralateral lobe, had pre-existing hypothyroidism, an autoimmune disease of the thyroid or were pregnant were excluded from the analysis. 33 patients were excluded due to additional surgery on the contralateral lobe resulting in a total of 426 patients. Pre-surgery ultrasound thyroid volume was calculated with the volumetric ellipsoid method (height × width × depth × correction factor 0.524).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
459

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who received a hemithyroidectomy at the Department of General Surgery, Division of Endocrine Surgery and a follow-up visit (3-12 months post-surgery) at the thyroid outpatient clinic of the Department of Endocrinology and Metabolism, Medical University of Vienna between 1994 and 2018 were identified and investigated in this retrospective study.

Description

Inclusion Criteria:

  • 18 years
  • Males and females
  • St.p. hemithyroidectomy

Exclusion Criteria:

  • Radiation therapy
  • Pregnancy
  • Previous thyroid surgery (e.g. nodule removal surgery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Left-side hemithyroidectomy
Patients who received a hemithyroidectomy of the left thyroid lobe since 1994
Procedure: Hemithyroidectomy
We investigated patients who received a hemithyroidectomy at the Department of General Surgery, Division of Endocrine Surgery and a follow-up visit (3-12 months post-surgery) at the thyroid outpatient clinic of the Department of Endocrinology and Metabolism, Medical University of Vienna between 1994 and 2018.
Right-side hemithyroidectomy
Patients who received a hemithyroidectomy of the right thyroid lobe since 1994
Procedure: Hemithyroidectomy
We investigated patients who received a hemithyroidectomy at the Department of General Surgery, Division of Endocrine Surgery and a follow-up visit (3-12 months post-surgery) at the thyroid outpatient clinic of the Department of Endocrinology and Metabolism, Medical University of Vienna between 1994 and 2018.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Levothyroxine dosage
Time Frame: within 3 to 12 months post surgery
dosage of levothyroxine needed post surgery, compared between left and right side hemithyroidectomy
within 3 to 12 months post surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hypothyroidism
Time Frame: within 3 to 12 months post surgery
Incidence of hypothyroidism post surgery compared between left and right side hemithyroidectomy
within 3 to 12 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lana Kosi-Trebotic, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Hemithyreoidectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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