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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03100357
Other study ID # SOLOIST4
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 14, 2017
Last updated March 28, 2017
Start date October 31, 2014
Est. completion date September 30, 2018

Study information

Verified date March 2017
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The pronounced effect of goiter on the esophagus needs further exploration, as the mechanisms by which goiter leads to swallowing difficulties are unknown. By investigating esophageal motility using high resolution esophageal manometry before and after thyroidectomy we seek to examine the impact of the goiter mass on the esophagus and swallowing with six months follow-up.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 39
Est. completion date September 30, 2018
Est. primary completion date March 2, 2017
Accepts healthy volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with symptomatic benign nodular goiter referred for thyroidectomy

Exclusion Criteria:

- Previous surgery to the neck;

- Suspicion of thyroid cancer

- Age below 20 years or above 80 years

- Neuromuscular disease.

Study Design


Intervention

Other:
Thyroidectomy
Thyroid surgery for benign nodular goiter

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Southern Denmark

Outcome

Type Measure Description Time frame Safety issue
Primary Motility disturbances Change in number of failed swallowings from baseline Before and six months following thyroidectomy
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