Benign Thyroid Nodules / Benign Goiter. What Subjective Problems Are Improved With an Operation and Can This be Predicted Preoperatively?
1 other identifier
observational
150
1 country
1
Brief Summary
Nodules in the thyroid gland are common. Patients discover these lumps either because of their visible size increase or because of local discomforts such as difficulty swallowing, difficulty breathing or voice changes. The thyroid gland is in close connection with the esophagus, trachea and the vocal nerve. Thus, a lump in the thyroid gland can cause pressure symptoms from these organs. In the event of such complaints, patients are referred for investigation. If it turns out that the patient has a lump in the thyroid gland ("goiter"), further investigation is carried out with an ultrasound examination and sampling with a needle from the lump (puncture). At present, most thyroid nodules are examined cytologically, ie the thyroid nodules are punctured with a thin needle and the cells that are obtained are analyzed by a cytologist. The material is graded according to Bethesda classification. Higher grading is associated with a higher risk that the tuber is malignant. Lower grading is associated with a lower probability that the tuber can be malignant. If these patients are operated on, it is usually with the hope that their local ailments improve. We want to investigate which patients who have a lump in the thyroid gland and experience pressure problems experience an improvement after a thyroid operation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Longer than P75 for all trials
1 active site
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
May 30, 2020
CompletedFirst Submitted
Initial submission to the registry
August 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedSeptember 2, 2022
September 1, 2022
4 years
August 16, 2022
September 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Symptom improvement
Which sypmtoms become better after hemithyroidectomy
One year follow upp
Secondary Outcomes (1)
Comparision of questionnaries
2024
Interventions
Hemithyroidectomy it is a surgical procedure where half of the thyroid gland is operated.
Eligibility Criteria
Patientens with compression symptoms in the neck
You may qualify if:
- Patients with a thyroid nodule who have local problems and where surgery (hemithyroidectomy) is planned
- years or older
- Bethesda I-IV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Linköpings University
Linköping, Östergötland County, 58729, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Oliver Gimm, Professor
Professor Oliver Gimm
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- General Surgeon MD
Study Record Dates
First Submitted
August 16, 2022
First Posted
September 2, 2022
Study Start
May 30, 2020
Primary Completion
May 30, 2024
Study Completion
May 30, 2024
Last Updated
September 2, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share