Higher Levothyroxine Requirements After Right-side Hemithyroidectomy

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT04648722
Collaborator
(none)
459
1
1.2
367.7

Study Details

Study Description

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 Phase
  • 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

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 :
Jun 12, 2020
Actual Study Completion Date :
Jun 12, 2020

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Levothyroxine dosage [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 [within 3 to 12 months post surgery]

    Incidence of hypothyroidism post surgery compared between left and right side hemithyroidectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Lana Kosi-Trebotic, Medical University of Vienna

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Carola Deischinger, Principal investigator, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04648722
Other Study ID Numbers:
  • Hemithyreoidectomy
First Posted:
Dec 1, 2020
Last Update Posted:
Dec 1, 2020
Last Verified:
Nov 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 Carola Deischinger, Principal investigator, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2020