Esophageal Motility DisordersNCT03100357
Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery
An observational study of Esophageal Motility Disorders, run by University of Southern Denmark.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Esophageal Motility Disorders
- What is being tested?
- Thyroidectomy
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2014to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with benign nodular goiter
Who may be able to join
- Patients with symptomatic benign nodular goiter referred for thyroidectomy
Who cannot join
- Previous surgery to the neck;
- Suspicion of thyroid cancer
- Age below 20 years or above 80 years
- Neuromuscular disease.
About this study
Official title: 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.
- Conditions
- Esophageal Motility Disorders
- Being tested
- Thyroidectomy
- Medical subject headings
- Esophageal Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroidectomyOther
Thyroid surgery for benign nodular goiter
What is being measured
The primary outcome is the main question the study is designed to answer.
Motility disturbances
Change in number of failed swallowings from baseline
Measured: Before and six months following thyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start31 Oct 2014
- Primary completion2 Mar 2017
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Motility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Roed Sorensen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100357
- Sponsor's protocol ID
- SOLOIST4
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29043407
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03100357
- Acronym / sponsor ID
- SOLOIST4
- Conditions
- Esophageal Motility Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 31 Oct 2014 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with benign nodular goiter
Key inclusion criteria (1 listed)
- Patients with symptomatic benign nodular goiter referred for thyroidectomy
Key exclusion criteria (4 listed)
- Previous surgery to the neck;
- Suspicion of thyroid cancer
- Age below 20 years or above 80 years
- Neuromuscular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThyroidectomyThyroid surgery for benign nodular goiter | Other | – |
Primary outcome
Motility disturbances
Time frame: Before and six months following thyroidectomy
Change in number of failed swallowings from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 29043407Sorensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Motility Disorders, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motility disturbances (time frame: Before and six months following thyroidectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03100357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.