- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07852026
Role of Total Thyroidectomy in Relieving Local Symptoms in Hashimoto's Thyroiditis
The Role of Total Thyroidectomy in Relieving Chronic Local Symptoms Associated With Hashimoto's Thyroiditis: Prospective Cohort Study
This study aims to evaluate the role and effectiveness of total thyroidectomy in relieving compressive and local symptoms (such as dysphagia, dyspnea, and anterior neck pain/discomfort) in patients with Hashimoto's thyroiditis who fail to improve with conservative medical management.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hashimoto's thyroiditis is a chronic autoimmune disease often presenting with goiter and local pressure symptoms. While levothyroxine replacement is standard for hypothyroidism, persistent compressive symptoms, cosmetic concerns, or suspicion of malignancy may necessitate surgical intervention.
This study investigates patients diagnosed with Hashimoto's thyroiditis presenting with significant local symptoms. Eligible patients undergoing total thyroidectomy will be evaluated preoperatively and postoperatively to assess symptom resolution, postoperative complication rates (such as hypocalcemia and recurrent laryngeal nerve injury), and overall patient satisfaction following surgery.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed Atef Muslim, Bachelor of Medicine and Surge
- Phone Number: +201099626447
- Email: ahmed.atef.465.aa@gmail.com
Study Locations
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-
Asyut Governorate
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Asyut, Asyut Governorate, Egypt, 71515
- Assiut University Hospitals
-
Contact:
- Ahmed Atef Muslim, Bachelor of Medicine and Surge
- Phone Number: +201099626447
- Email: ahmed.atef.465.aa@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients diagnosed with Hashimoto's thyroiditis who suffer from persistent local compressive symptoms and undergo total thyroidectomy at the Department of Surgery, Assiut University Hospitals.
Description
Inclusion Criteria:
- Adults patients with confirmed Hashimoto's thyroiditis (elevated serum anti-thyroid peroxidase \anti-thyroglobulin antibodies, characteristic ultrasound findings and/or positive fine needle aspiration cytology)
- Biochemically euthyroid with normal thyroid function test.
- Presence of persistent local symptoms (neck pain, throat discomfort,neck tightness,chocking) for more than 6 months
- Patient fit and motivated to surgery.
Exclusion Criteria:
- Confirmed or high-suspicion thyroid malignancy (Bethesda V or IV on FNAC
- Previous thyroid or neck surgery
- Patient refusal to participate in the study
- Severe comorbidities precluding general anesthesia
- Active psychiatric illness
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 |
|---|---|---|
|
Improvement or Relief of Local Compressive Symptoms
Time Frame: 6 months postoperatively
|
Assessment of changes in patient-reported compressive symptoms (such as dysphagia, dyspnea, and local neck discomfort or pressure) following total thyroidectomy compared to baseline status. |
6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Postoperative Complications
Time Frame: Up to 30 days postoperatively
|
Rate of surgical complications including transient or permanent hypocalcemia, recurrent laryngeal nerve injury, and wound complications. |
Up to 30 days postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ahmed Gamal Hamdan, Lecturer
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hashimoto's Thyroiditis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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