Five-year Follow up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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.
Outcomes
Primary Outcomes
Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.
Time Frame: at 12, 24, 36, 48 and 60 months after surgery
Secondary Outcomes
- 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)