NCT02468921

Brief Summary

The aim of the study is to investigate the influence benign non-toxic goitre and the surgical treatment hereof on the voice function before and 6 months following surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

3.9 years

First QC Date

January 19, 2015

Last Update Submit

November 7, 2016

Conditions

Goiter

Keywords

Goitrethyroid diseasestruma

Outcome Measures

Primary Outcomes (1)

  • Number of patients with changed frequency range in voice function following thyroidectomy

    Change in frequency range (Hz) of the Voice Range Profiler Phonetogram from baseline to 6 months after surgery.

    6 months

Interventions

ThyroidectomyPROCEDURE

Regular thyroidectomy or hemithyroidectomy through Kocher's skin incision

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing hemi- or total thyroidectomy at Odense University Hospital for benign symptomatic non-toxic goiter

You may qualify if:

  • Patients undergoing hemi- or total thyroidectomy for benign non-toxic goiter with pressure symptoms
  • The patients must be able to understand, write and read Danish

You may not qualify if:

  • Previous surgery to the neck
  • Diabetes or any neuromuscular disorders.
  • Present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

GoiterThyroid Diseases

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Christian Godballe, Professor

    University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 19, 2015

First Posted

June 11, 2015

Study Start

November 1, 2014

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

DK(1)