Subtotal Versus Total Thyroidectomy for Benign Goiter

NCT01273714 | Completed DMC

• 1 other identifier: BBN/501/ZKL/87/L
• Study Type: interventional
• Target: 8,006
• Locations: 1 country
• Sites: 1

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.

Conditions

Goiter

Keywords

benign thyroid disease; incidental thyroid cancer; recurrent goiter; revision thyroid surgery

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure was the prevalence of recurrent goiter, incidental thyroid cancer and need for revision thyroid surgery.

  folow-up at yearly intervals following thyroidectomy

Secondary Outcomes (1)

• Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding).

  12-month follow-up after thyroidectomy

Study Arms (2)

BST

ACTIVE COMPARATOR

bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each)

Procedure: thyroid resection

TT

EXPERIMENTAL

extracapsular total thyroidectomy

Procedure: thyroid resection

Interventions

thyroid resection PROCEDURE

bilateral subtotal versus total thyroidectomy

BST; TT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a benign bilateral thyroid disease with the posterior aspects of both thyroid lobes appearing normal on ultrasound of the neck.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian Univerity, Medical College, 3rd Department of general Surgery

Krakow, Malopolska, 31-202, Poland

Location

Related Publications (9)

• 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.

  PMID: 17308855 BACKGROUND

• 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.

  PMID: 10326531 BACKGROUND

• 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.

  PMID: 15863948 BACKGROUND

• 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.

  PMID: 18305998 BACKGROUND

• 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.

  PMID: 18958517 BACKGROUND

• 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.

  PMID: 18449595 BACKGROUND

• 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.

  PMID: 18311576 BACKGROUND

• 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.

  PMID: 19177420 BACKGROUND

• 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.

  PMID: 22005150 DERIVED

MeSH Terms

Conditions

Goiter

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Marcin Barczynski, MD, PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: January 1, 1999
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2009
• Last Updated: January 10, 2011

Record last verified: 2011-01

Locations

PL (1)