Benign Thyroid Nodules / Benign Goiter. What Subjective Problems Are Improved With an Operation and Can This be Predicted Preoperatively?

Thyroid Nodule Clinical Trial

Official title:

Benign Thyroid Nodules / Benign Goiter. What Subjective Problems Are Improved With an Operation and Can This be Predicted Preoperatively?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526261
• Other study ID #: 2020-00022
• Status: Recruiting
• Start date: May 30, 2020
• Est. completion date: May 30, 2024

Study information

• Verified date: September 2022
• Source: Linkoeping University
• Contact: Ervin Beka
• Phone: 0738430968
• Email: ervin.beka[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a thyroid nodule who have local problems and where surgery (hemithyroidectomy) is planned

• 18 years or older

• Bethesda I-IV

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Procedure:
• Hemithyroidectoy
Hemithyroidectomy it is a surgical procedure where half of the thyroid gland is operated.

Locations

Country	Name	City	State
Sweden	Linköpings University	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom improvement	Which sypmtoms become better after hemithyroidectomy	One year follow upp
Secondary	Comparision of questionnaries	The patients are going to fill in 4 different questionnaries in 3 different time intervalls. Before the operation, 1 month and 1 year efter the operation.	2024