Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter
Primary Purpose
Goiter
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Total thyroidectomy
Dunhill operation
Bilateral subtotal thyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Goiter focused on measuring Total thyroidectomy, Subtotal thyroidectomy, Dunhill operation, Recurrent nodular goiter, Completion thyroidectomy, Recurrent laryngeal nerve palsy, Hypoparathyroidism following thyroidectomy, Recurrent goiter
Eligibility Criteria
Inclusion Criterion
- a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes.
Exclusion Criteria:
- multinodular goiter involving posterior aspect/s of thyroid lobe/s,
- suspicion of thyroid cancer,
- previous thyroid surgery,
- thyroiditis,
- subclinical or clinically overt hypothyroidism or hyperthyroidism,
- pregnancy or lactation,
- age < 18 years or > 65 years,
- ASA 4 grade (American Society of Anesthesiology),
- inability to comply with the follow-up protocol.
Sites / Locations
- Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Total thyroidectomy
Dunhill operation
Bilateral subtotal thyroidectomy
Arm Description
Patients who underwent total thyroidectomy
Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
Patients who underwent bilateral subtotal thyroidectomy
Outcomes
Primary Outcome Measures
Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.
Secondary Outcome Measures
Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00946894
Brief Title
Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter
Official Title
Five-year Follow up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Jagiellonian University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this three-arm randomized study was to evaluate results of different thyroid resection modes among patients with bilateral multinodular non-toxic goiter, with special emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.
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 prospective randomized 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
Total thyroidectomy, Subtotal thyroidectomy, Dunhill operation, Recurrent nodular goiter, Completion thyroidectomy, Recurrent laryngeal nerve palsy, Hypoparathyroidism following thyroidectomy, Recurrent goiter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total thyroidectomy
Arm Type
Experimental
Arm Description
Patients who underwent total thyroidectomy
Arm Title
Dunhill operation
Arm Type
Experimental
Arm Description
Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
Arm Title
Bilateral subtotal thyroidectomy
Arm Type
Active Comparator
Arm Description
Patients who underwent bilateral subtotal thyroidectomy
Intervention Type
Procedure
Intervention Name(s)
Total thyroidectomy
Other Intervention Name(s)
TT
Intervention Description
Total thyroidectomy
Intervention Type
Procedure
Intervention Name(s)
Dunhill operation
Other Intervention Name(s)
DO
Intervention Description
Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
Intervention Type
Procedure
Intervention Name(s)
Bilateral subtotal thyroidectomy
Other Intervention Name(s)
BST
Intervention Description
Bilateral subtotal thyroidectomy
Primary Outcome Measure Information:
Title
Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.
Time Frame
at 12, 24, 36, 48 and 60 months after surgery
Secondary Outcome Measure Information:
Title
Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).
Time Frame
at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery
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 Criterion
a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes.
Exclusion Criteria:
multinodular goiter involving posterior aspect/s of thyroid lobe/s,
suspicion of thyroid cancer,
previous thyroid surgery,
thyroiditis,
subclinical or clinically overt hypothyroidism or hyperthyroidism,
pregnancy or lactation,
age < 18 years or > 65 years,
ASA 4 grade (American Society of Anesthesiology),
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 College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
City
Krakow
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
28942461
Citation
Barczynski M, Konturek A, Hubalewska-Dydejczyk A, Golkowski F, Nowak W. Ten-Year Follow-Up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter. World J Surg. 2018 Feb;42(2):384-392. doi: 10.1007/s00268-017-4230-1.
Results Reference
derived
PubMed Identifier
20174803
Citation
Barczynski M, Konturek A, Hubalewska-Dydejczyk A, Golkowski F, Cichon S, Nowak W. Five-year follow-up of a randomized clinical trial of total thyroidectomy versus Dunhill operation versus bilateral subtotal thyroidectomy for multinodular nontoxic goiter. World J Surg. 2010 Jun;34(6):1203-13. doi: 10.1007/s00268-010-0491-7.
Results Reference
derived
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Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter
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