Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

Study Overview
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Brief Summary
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The aim of this three-arm randomized study was to evaluate results of different thyroid resection modes among patients with bilateral multinodular non-toxic goiter, with special emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.

Detailed Description
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The extent of thyroid resection in bilateral multinodular non-toxic goiter remains controversial. Surgeons still continue to debate whether the potential benefits of total thyroidectomy outweigh the potential complications. Most low-volume surgeons avoid to perform total thyroidectomy owing to the possible complications such as permanent recurrent laryngeal nerve palsy and permanent hypoparathyroidism. On the other hand, the increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indication for this procedure include thyroid cancer, Graves disease and multinodular goiter. Recently there has been increasing acceptance for performing total thyroidectomy for bilateral multinodular non-toxic goiter as it removes the disease process completely, lowers local recurrence rate and avoids the substantial risk of reoperative surgery, and involves only a minimal risk of morbidity. This common perception is based largely on single-institution retrospective data, a few multi-institutional retrospective experiences, and only a few prospective randomized studies comparing the outcomes of total vs. subtotal thyroidectomy.

Official Title
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Five-year Follow up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter.

Conditions
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Goiter

Intervention / Treatment
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* Procedure: Total thyroidectomy
* Procedure: Dunhill operation
* Procedure: Bilateral subtotal thyroidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criterion a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes. Exclusion Criteria: multinodular goiter involving posterior aspect/s of thyroid lobe/s, suspicion of thyroid cancer, previous thyroid surgery, thyroiditis, subclinical or clinically overt hypothyroidism or hyperthyroidism, pregnancy or lactation, age < 18 years or > 65 years, ASA 4 grade (American Society of Anesthesiology), inability to comply with the follow-up protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total thyroidectomy<br>Patients who underwent total thyroidectomy | Procedure: Total thyroidectomy<br>* Total thyroidectomy<br>* Other names: TT;|
| Experimental: Dunhill operation<br>Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy | Procedure: Dunhill operation<br>* Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy<br>* Other names: DO;|
| Active Comparator: Bilateral subtotal thyroidectomy<br>Patients who underwent bilateral subtotal thyroidectomy | Procedure: Bilateral subtotal thyroidectomy<br>* Bilateral subtotal thyroidectomy<br>* Other names: BST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measure was prevalence of recurrent goiter and need for redo surgery. |  | at 12, 24, 36, 48 and 60 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury). |  | at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total thyroidectomy, Subtotal thyroidectomy, Dunhill operation, Recurrent nodular goiter, Completion thyroidectomy, Recurrent laryngeal nerve palsy, Hypoparathyroidism following thyroidectomy, Recurrent goiter