ClinicalTrials.gg
Status unknownNCT02468921SOLOISTUpdated Nov 8, 2016

Goitres Influence on Voice Function - The Impact of Surgery

An observational study in Goiter, sponsored by University of Southern Denmark. Status unknown at 1 site in Denmark. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-08.

Sponsored by University of Southern Denmark · Observational

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Goiter

Keywords

  • Goitre
  • thyroid disease
  • struma
03

In context

Goiter

66 studies on the registry are indexed under Goiter; 11 are open to participants now.

This study's planned enrollment of 60 is below the median of 104 across 23 observational studies indexed under Goiter.

Browse Goiter studies →

Lead sponsor

University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria:

  • Previous surgery to the neck
  • Diabetes or any neuromuscular disorders.
  • Present or previous head and neck , including malignancy found in the surgical thyroid specimen or suspicion hereof.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Interventions

  • ProcedureThyroidectomy

    Regular thyroidectomy or hemithyroidectomy through Kocher's skin incision

06

What researchers measure

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.

    Time frame: 6 months

07

Study locations

1 site
  • Odense University Hospital
    Odense, 5000, Denmark
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2014, a primary completion of Oct 2018 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2015
First posted
Jun 11, 2015
Start
Nov 2014
Primary completionEst.
Oct 2018
CompletionEst.
Oct 2018
Last update
Nov 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02468921
Responsible party
Jesper Roed Sorensen (MD, University of Southern Denmark) — Principal investigator
First posted
Jun 11, 2015
Start date
Nov 2014
Primary completion
Oct 2018 (estimated)
Completion
Oct 2018 (estimated)
Last update
Nov 8, 2016

Study contacts

Christian Godballe, Professor
study director · University of Southern Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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