Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04648722
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2020-11-22
Brief Title:
Higher Levothyroxine Requirements After Right-side Hemithyroidectomy
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Higher Post-operative Levothyroxine Substitution Dose Needed in Right Compared to Left Lobe Hemithyroidectomy - a Retrospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 0524
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 0524
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None