Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

Goiter Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946894
• Other study ID #: BBN/501/ZKL/68/L
• Status: Completed
• Phase: N/A
• First received: July 23, 2009
• Last updated: July 24, 2009
• Start date: January 2000
• Est. completion date: December 2008

Study information

• Verified date: July 2009
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2008
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Goiter

Intervention

Procedure:
• Total thyroidectomy
Total thyroidectomy
• Dunhill operation
Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
• Bilateral subtotal thyroidectomy
Bilateral subtotal thyroidectomy

Locations

Country	Name	City	State
Poland	Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (8)

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. Review. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Wheeler MH. Total thyroidectomy for benign thyroid disease. Lancet. 1998 May 23;351(9115):1526-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.		at 12, 24, 36, 48 and 60 months after surgery	Yes
Secondary	Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).		at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery	Yes