Clinical trial NCT00946894: 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
Overall status: COMPLETED
Phase: NA
Conditions: Goiter
Keywords: Total thyroidectomy
Subtotal thyroidectomy
Dunhill operation
Recurrent nodular goiter
Completion thyroidectomy
Recurrent laryngeal nerve palsy
Hypoparathyroidism following thyroidectomy
Recurrent goiter
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.
timeFrame: at 12, 24, 36, 48 and 60 months after surgery
Secondary outcomes:
measure: Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).
timeFrame: at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
Study officials:
affiliation: Jagiellonian University College of Medicine
name: Marcin Barczynski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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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.
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.
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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.
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.
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.