Subtotal Versus Total Thyroidectomy for Benign Goiter
Primary Purpose
Goiter
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
thyroid resection
Sponsored by
About this trial
This is an interventional treatment trial for Goiter focused on measuring benign thyroid disease, incidental thyroid cancer, recurrent goiter, revision thyroid surgery
Eligibility Criteria
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.
Sites / Locations
- Jagiellonian Univerity, Medical College, 3rd Department of general Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
BST
TT
Arm Description
bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each)
extracapsular total thyroidectomy
Outcomes
Primary Outcome Measures
Primary outcome measure was the prevalence of recurrent goiter, incidental thyroid cancer and need for revision thyroid surgery.
Secondary Outcome Measures
Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding).
Full Information
NCT ID
NCT01273714
First Posted
January 7, 2011
Last Updated
January 7, 2011
Sponsor
Jagiellonian University
1. Study Identification
Unique Protocol Identification Number
NCT01273714
Brief Title
Subtotal Versus Total Thyroidectomy for Benign Goiter
Official Title
Subtotal Versus Total Thyroidectomy for Benign Thyroid Disease - a Prospective Case-control Surgical Outcome Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Jagiellonian University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Goiter
Keywords
benign thyroid disease, incidental thyroid cancer, recurrent goiter, revision thyroid surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8006 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BST
Arm Type
Active Comparator
Arm Description
bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each)
Arm Title
TT
Arm Type
Experimental
Arm Description
extracapsular total thyroidectomy
Intervention Type
Procedure
Intervention Name(s)
thyroid resection
Intervention Description
bilateral subtotal versus total thyroidectomy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding).
Time Frame
12-month follow-up after thyroidectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Barczynski, MD, PhD
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jagiellonian Univerity, Medical College, 3rd Department of general Surgery
City
Krakow
State/Province
Malopolska
ZIP/Postal Code
31-202
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
17308855
Citation
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.
Results Reference
background
PubMed Identifier
10326531
Citation
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.
Results Reference
background
PubMed Identifier
15863948
Citation
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.
Results Reference
background
PubMed Identifier
18305998
Citation
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.
Results Reference
background
PubMed Identifier
18958517
Citation
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.
Results Reference
background
PubMed Identifier
18449595
Citation
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.
Results Reference
background
PubMed Identifier
18311576
Citation
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.
Results Reference
background
PubMed Identifier
19177420
Citation
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.
Results Reference
background
PubMed Identifier
22005150
Citation
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.
Results Reference
derived
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Subtotal Versus Total Thyroidectomy for Benign Goiter
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