Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04648722 |
| Other study ID # |
Hemithyreoidectomy |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2020 |
| Est. completion date |
June 12, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Medical University of Vienna |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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).
