Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery

March 28, 2017 updated by: Jesper Roed Sorensen, University of Southern Denmark

Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery - a Prospective Cohort Study

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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

39

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

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with benign nodular goiter

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motility disturbances
Time Frame: Before and six months following thyroidectomy
Change in number of failed swallowings from baseline
Before and six months following thyroidectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 31, 2014

Primary Completion (Actual)

March 2, 2017

Study Completion (Anticipated)

September 30, 2018

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Esophageal Motility Disorders

Clinical Trials on Thyroidectomy

3
Subscribe