- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02651818
Changes in Quality of Life Following Surgical Treatment of Benign Non-toxic Goiter (SOLOIST)
May 14, 2018 updated by: Jesper Roed Sorensen, University of Southern Denmark
The Impact of Surgical Treatment of Benign Non-toxic Goiter on Quality of Life
The aim is to investigate the influence of surgical treatment on benign non-toxic goiter on the disease specific quality of life evaluated 6 months after thyroid surgery.
All investigations follow already scheduled treatments.
Study Overview
Study Type
Observational
Enrollment (Actual)
104
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Odense, Denmark, 5000
- Odense University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients undergoing hemi- or total thyroidectomy at Odense University Hospital for benign symptomatic non-toxic goiter
Description
Inclusion Criteria:
- Patients undergoing hemi- or total thyroidectomy for benign non-toxic goiter with pressure symptoms
- The patients must be able to understand, read and write Danish
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life following thyroidectomy
Time Frame: 6 months
|
Change in goiter symptom score at the Thyroid specific Patient Reported Outcome measure (ThyPRO) following thyroidectomy
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Christian Godballe, Professor, University of Southern Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2014
Primary Completion (Actual)
October 24, 2017
Study Completion (Actual)
October 24, 2017
Study Registration Dates
First Submitted
January 6, 2016
First Submitted That Met QC Criteria
January 8, 2016
First Posted (Estimate)
January 11, 2016
Study Record Updates
Last Update Posted (Actual)
May 15, 2018
Last Update Submitted That Met QC Criteria
May 14, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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