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Subtotal Versus Total Thyroidectomy for Benign Goiter

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT01273714
First received: January 7, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 7, 2011
January 7, 2011
January 1999
December 2004   (final data collection date for primary outcome measure)
Primary outcome measure was the prevalence of recurrent goiter, incidental thyroid cancer and need for revision thyroid surgery. [ Time Frame: folow-up at yearly intervals following thyroidectomy ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding). [ Time Frame: 12-month follow-up after thyroidectomy ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Subtotal Versus Total Thyroidectomy for Benign Goiter
Subtotal Versus Total Thyroidectomy for Benign Thyroid Disease - a Prospective Case-control Surgical Outcome Study.

The extent of thyroid resection in benign goiter is controversial. Potential advantages of TT over BST may include: one-stage removal of incidental thyroid cancer reported in up to 10% of operatively treated benign thyroid diseases, and lower risk for goiter recurrence. However, these potential advantages should outweigh the risk of morbidity associated with more radical thyroid resection.

The aim of this study was to compare outcomes of bilateral subtotal (BST) vs. total thyroidectomy (TT) for benign bilateral thyroid disease.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Goiter
Procedure: thyroid resection
bilateral subtotal versus total thyroidectomy
  • Active Comparator: BST
    bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each)
    Intervention: Procedure: thyroid resection
  • Experimental: TT
    extracapsular total thyroidectomy
    Intervention: Procedure: thyroid resection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8006
December 2009
December 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01273714
BBN/501/ZKL/87/L
Yes
Not Provided
Jagiellonian University
Not Provided
Principal Investigator: Marcin Barczynski, MD, PhD Jagiellonian University, Medical College
Jagiellonian University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP