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Higher Levothyroxine Requirements After Right-side Hemithyroidectomy

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ClinicalTrials.gov Identifier: NCT04648722
Recruitment Status : Completed
First Posted : December 1, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Carola Deischinger, Medical University of Vienna

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Hemithyroidectomy Hypothyroidism Procedure: Hemithyroidectomy

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 Design
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Study Type : Observational
Actual Enrollment : 459 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Higher Post-operative Levothyroxine Substitution Dose Needed in Right Compared to Left Lobe Hemithyroidectomy - a Retrospective Cohort Study
Actual Study Start Date : May 5, 2020
Actual Primary Completion Date : June 12, 2020
Actual Study Completion Date : June 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Levothyroxine dosage [ Time Frame: within 3 to 12 months post surgery ]
    dosage of levothyroxine needed post surgery, compared between left and right side hemithyroidectomy


Secondary Outcome Measures :
  1. Hypothyroidism [ Time Frame: within 3 to 12 months post surgery ]
    Incidence of hypothyroidism post surgery compared between left and right side hemithyroidectomy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Radiation therapy
  • Pregnancy
  • Previous thyroid surgery (e.g. nodule removal surgery)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648722


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Lana Kosi-Trebotic Medical University of Vienna
  Study Documents (Full-Text)

Documents provided by Carola Deischinger, Medical University of Vienna:
Study Protocol and Statistical Analysis Plan  [PDF] February 20, 2020

More Information
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Responsible Party: Carola Deischinger, Principal investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04648722    
Other Study ID Numbers: Hemithyreoidectomy
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carola Deischinger, Medical University of Vienna:
Hemithyroidectomy
Levothyroxine
Postoperative levothyroxine requirements
Lobectomy
Thyroid
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases