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Completed

NCT Number: NCT04648722

Higher Levothyroxine Requirements After Right-side Hemithyroidectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hemithyroidectomy

Procedure

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.

Primary outcomes

  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 outcomes

  1. Hypothyroidism

    Time frame: within 3 to 12 months post surgery

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 1, 2020
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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