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

• Sponsor: University of Southern Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT02651818
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Actual Duration (Months): 35.8
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Goiter	Procedure: Thyroidectomy

Study Design

• Study Type: Observational
• Actual Enrollment: 104 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Impact of Surgical Treatment of Benign Non-toxic Goiter on Quality of Life
• Actual Study Start Date: Oct 30, 2014
• Actual Primary Completion Date: Oct 24, 2017
• Actual Study Completion Date: Oct 24, 2017

Outcome Measures

Primary Outcome Measures

1. Change in quality of life following thyroidectomy [6 months]

   Change in goiter symptom score at the Thyroid specific Patient Reported Outcome measure (ThyPRO) following thyroidectomy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

• University of Southern Denmark

Investigators

• Study Director: Christian Godballe, Professor, University of Southern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jesper Roed Sorensen, MD, University of Southern Denmark
• ClinicalTrials.gov Identifier: NCT02651818
• Other Study ID Numbers: S-20132
• First Posted: Jan 11, 2016
• Last Update Posted: May 15, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Jesper Roed Sorensen, MD, University of Southern Denmark: Goiter; Thyroid disease; Struma
• Additional relevant MeSH terms: Goiter

Study Results

No Results Posted as of May 15, 2018