Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

Jagiellonian University

Status: Completed

Conditions: Goiter

Treatments: Procedure: Bilateral subtotal thyroidectomy; Procedure: Dunhill operation; Procedure: Total thyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00946894

BBN/501/ZKL/68/L

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 3 patient groups

Total thyroidectomy

Experimental group

Description:

Patients who underwent total thyroidectomy

Treatment:

Procedure: Total thyroidectomy

Dunhill operation

Experimental group

Description:

Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy

Treatment:

Procedure: Dunhill operation

Bilateral subtotal thyroidectomy

Active Comparator group

Description:

Patients who underwent bilateral subtotal thyroidectomy

Treatment:

Procedure: Bilateral subtotal thyroidectomy