Clinical Trial: Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Jagiellonian University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Jagiellonian University

Dates:
Date Received: July 23, 2009
Date Started: January 2000
Date Completion:
Last Updated: July 24, 2009
Last Verified: July 2009