Subtotal Versus Total Thyroidectomy for Benign Goiter
January 7, 2011 updated by: Jagiellonian University
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
8006
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Malopolska
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Krakow, Malopolska, Poland, 31-202
- Jagiellonian Univerity, Medical College, 3rd Department of general Surgery
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
bilateral subtotal versus total thyroidectomy
|
|
Experimental: TT
extracapsular total thyroidectomy
|
bilateral subtotal versus total thyroidectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
folow-up at yearly intervals following thyroidectomy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding).
Time Frame: 12-month follow-up after thyroidectomy
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12-month follow-up after thyroidectomy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Snook KL, Stalberg PL, Sidhu SB, Sywak MS, Edhouse P, Delbridge L. Recurrence after total thyroidectomy for benign multinodular goiter. World J Surg. 2007 Mar;31(3):593-8; discussion 599-600. doi: 10.1007/s00268-006-0135-0.
- Wheeler MH. Total thyroidectomy for benign thyroid disease. Lancet. 1998 May 23;351(9115):1526-7. doi: 10.1016/S0140-6736(05)61116-6. No abstract available.
- Ozbas S, Kocak S, Aydintug S, Cakmak A, Demirkiran MA, Wishart GC. Comparison of the complications of subtotal, near total and total thyroidectomy in the surgical management of multinodular goitre. Endocr J. 2005 Apr;52(2):199-205. doi: 10.1507/endocrj.52.199.
- Moalem J, Suh I, Duh QY. Treatment and prevention of recurrence of multinodular goiter: an evidence-based review of the literature. World J Surg. 2008 Jul;32(7):1301-12. doi: 10.1007/s00268-008-9477-0.
- Tezelman S, Borucu I, Senyurek Giles Y, Tunca F, Terzioglu T. The change in surgical practice from subtotal to near-total or total thyroidectomy in the treatment of patients with benign multinodular goiter. World J Surg. 2009 Mar;33(3):400-5. doi: 10.1007/s00268-008-9808-1.
- Agarwal G, Aggarwal V. Is total thyroidectomy the surgical procedure of choice for benign multinodular goiter? An evidence-based review. World J Surg. 2008 Jul;32(7):1313-24. doi: 10.1007/s00268-008-9579-8.
- Phitayakorn R, McHenry CR. Follow-up after surgery for benign nodular thyroid disease: evidence-based approach. World J Surg. 2008 Jul;32(7):1374-84. doi: 10.1007/s00268-008-9487-y.
- Barczynski M, Konturek A, Cichon S. Randomized clinical trial of visualization versus neuromonitoring of recurrent laryngeal nerves during thyroidectomy. Br J Surg. 2009 Mar;96(3):240-6. doi: 10.1002/bjs.6417.
- Barczynski M, Konturek A, Stopa M, Cichon S, Richter P, Nowak W. Total thyroidectomy for benign thyroid disease: is it really worthwhile? Ann Surg. 2011 Nov;254(5):724-29; discussion 729-30. doi: 10.1097/SLA.0b013e3182360118.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1999
Primary Completion (Actual)
December 1, 2004
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
January 7, 2011
First Submitted That Met QC Criteria
January 7, 2011
First Posted (Estimate)
January 10, 2011
Study Record Updates
Last Update Posted (Estimate)
January 10, 2011
Last Update Submitted That Met QC Criteria
January 7, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBN/501/ZKL/87/L
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