Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery
Sponsor
University of Southern Denmark (Other)
Overall Status
Unknown status
CT.gov ID
NCT03100357
Collaborator
(none)
39
47
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
39 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery - a Prospective Cohort Study
Actual Study Start Date
:
Oct 31, 2014
Actual Primary Completion Date
:
Mar 2, 2017
Anticipated Study Completion Date
:
Sep 30, 2018
Outcome Measures
Primary Outcome Measures
- Motility disturbances [Before and six months following thyroidectomy]
Change in number of failed swallowings from baseline
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 80 Years
Sexes Eligible for Study:
All
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Southern Denmark
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Jesper Roed Sorensen,
MD PhD fellow,
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT03100357
Other Study ID Numbers:
- SOLOIST4
First Posted:
Apr 4, 2017
Last Update Posted:
Apr 4, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: