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Subtotal Versus Total Thyroidectomy for Benign Goiter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01273714
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : January 10, 2011
Information provided by:
Jagiellonian University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Goiter Procedure: thyroid resection Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8006 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subtotal Versus Total Thyroidectomy for Benign Thyroid Disease - a Prospective Case-control Surgical Outcome Study.
Study Start Date : January 1999
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arm Intervention/treatment
Active Comparator: BST
bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each)
Procedure: thyroid resection
bilateral subtotal versus total thyroidectomy

Experimental: TT
extracapsular total thyroidectomy
Procedure: thyroid resection
bilateral subtotal versus total thyroidectomy

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding). [ Time Frame: 12-month follow-up after thyroidectomy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01273714

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Jagiellonian Univerity, Medical College, 3rd Department of general Surgery
Krakow, Malopolska, Poland, 31-202
Sponsors and Collaborators
Jagiellonian University
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Principal Investigator: Marcin Barczynski, MD, PhD Jagiellonian University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT01273714    
Other Study ID Numbers: BBN/501/ZKL/87/L
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: January 2011
Keywords provided by Jagiellonian University:
benign thyroid disease
incidental thyroid cancer
recurrent goiter
revision thyroid surgery
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases