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Subtotal Versus Total Thyroidectomy for Benign Thyroid Disease - a Prospective Case-control Surgical Outcome Study.


N/A
18 Years
65 Years
Not Enrolling
Both
Goiter

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Trial Information

Subtotal Versus Total Thyroidectomy for Benign Thyroid Disease - a Prospective Case-control Surgical Outcome Study.


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 small prospective studies comparing the outcomes of total vs.
subtotal thyroidectomy.


Inclusion Criteria:



- a benign bilateral thyroid disease with the posterior aspects of both thyroid lobes
appearing normal on ultrasound of the neck.

Exclusion Criteria:

- thyroid disease involving the posterior aspect/s of thyroid lobe/s,

- suspicion of thyroid cancer,

- previous thyroid surgery,

- pregnancy or lactation,

- age < 18 years or > 65 years,

- ASA 4 grade (American Society of Anesthesiology),

- and inability to comply with the follow-up protocol.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary outcome measure was the prevalence of recurrent goiter, incidental thyroid cancer and need for revision thyroid surgery.

Outcome Time Frame:

folow-up at yearly intervals following thyroidectomy

Safety Issue:

No

Principal Investigator

Marcin Barczynski, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jagiellonian University, Medical College

Authority:

Poland: Ministry of Health

Study ID:

BBN/501/ZKL/87/L

NCT ID:

NCT01273714

Start Date:

January 1999

Completion Date:

December 2009

Related Keywords:

  • Goiter
  • benign thyroid disease
  • incidental thyroid cancer
  • recurrent goiter
  • revision thyroid surgery
  • Goiter
  • Thyroid Diseases

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