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

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Nodule
• Intervention / Treatment: Procedure: Hemithyroidectoy

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Ervin Beka; Phone Number: 0738430968; Email: ervin.beka@regionostergotland.se

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, 58729
      • Recruiting
      • Linköpings University
      • Contact: Ervin Beka; Phone Number: 0738430968; Email: ervin.beka@regionostergotland.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patientens with compression symptoms in the neck

Description

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:

-

Study Plan

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
Symptom improvement	Which sypmtoms become better after hemithyroidectomy	One year follow upp

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Study Director: Oliver Gimm, Professor, Professor Oliver Gimm

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2020
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: 2020-00022

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