NCT03100357

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

March 14, 2017

Last Update Submit

March 28, 2017

Conditions

Esophageal Motility Disorders

Outcome Measures

Primary Outcomes (1)

  • Motility disturbances

    Change in number of failed swallowings from baseline

    Before and six months following thyroidectomy

Interventions

ThyroidectomyOTHER

Thyroid surgery for benign nodular goiter

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with benign nodular goiter

You may qualify if:

  • Patients with symptomatic benign nodular goiter referred for thyroidectomy

You may not qualify if:

  • Previous surgery to the neck;
  • Suspicion of thyroid cancer
  • Age below 20 years or above 80 years
  • Neuromuscular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sorensen JR, Markoew S, Dossing H, Hegedus L, Bonnema SJ, Godballe C. Changes in Swallowing Symptoms and Esophageal Motility After Thyroid Surgery: A Prospective Cohort Study. World J Surg. 2018 Apr;42(4):998-1004. doi: 10.1007/s00268-017-4247-5.

    PMID: 29043407DERIVED

MeSH Terms

Conditions

Esophageal Motility Disorders

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Deglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD fellow

Study Record Dates

First Submitted

March 14, 2017

First Posted

April 4, 2017

Study Start

October 31, 2014

Primary Completion

March 2, 2017

Study Completion

September 30, 2018

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share