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NCT02651818 Clinical Trial

Changes in Quality of Life Following Surgical Treatment of Benign Non-toxic Goiter

Goiter Clinical Trial

— SOLOIST  

Official title:
The Impact of Surgical Treatment of Benign Non-toxic Goiter on Quality of Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02651818
Other study ID # S-20132
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 30, 2014
Est. completion date October 24, 2017

Study information
Verified date May 2018
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date October 24, 2017
Est. primary completion date October 24, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Thyroidectomy
Regular thyroidectomy or hemithyroidectomy through Kocher's skin incision

Locations
Country Name City State
Denmark Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in quality of life following thyroidectomy Change in goiter symptom score at the Thyroid specific Patient Reported Outcome measure (ThyPRO) following thyroidectomy 6 months
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