NCT04648722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 22, 2020

Last Update Submit

November 28, 2020

Conditions

Keywords

HemithyroidectomyLevothyroxinePostoperative levothyroxine requirementsLobectomyThyroid

Outcome Measures

Primary Outcomes (1)

  • Levothyroxine dosage

    dosage of levothyroxine needed post surgery, compared between left and right side hemithyroidectomy

    within 3 to 12 months post surgery

Secondary Outcomes (1)

  • Hypothyroidism

    within 3 to 12 months post surgery

Study Arms (2)

Left-side hemithyroidectomy

Patients who received a hemithyroidectomy of the left thyroid lobe since 1994

Procedure: Hemithyroidectomy

Right-side hemithyroidectomy

Patients who received a hemithyroidectomy of the right thyroid lobe since 1994

Procedure: Hemithyroidectomy

Interventions

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.

Left-side hemithyroidectomyRight-side hemithyroidectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

HypothyroidismThyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Lana Kosi-Trebotic

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 22, 2020

First Posted

December 1, 2020

Study Start

May 5, 2020

Primary Completion

June 12, 2020

Study Completion

June 12, 2020

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations