Subtotal Versus Total Thyroidectomy for Benign Goiter

NCT ID: NCT01273714

Last Updated: 2011-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8006 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

Goiter

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BST

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

Group Type: ACTIVE_COMPARATOR

thyroid resection

Intervention Type: PROCEDURE

bilateral subtotal versus total thyroidectomy

TT

extracapsular total thyroidectomy

Group Type: EXPERIMENTAL

thyroid resection

Intervention Type: PROCEDURE

bilateral subtotal versus total thyroidectomy

Interventions

thyroid resection

bilateral subtotal versus total thyroidectomy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Principal Investigators

Marcin Barczynski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

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

Krakow, Malopolska, Poland

Countries

Poland

References

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.

Reference Type: BACKGROUND

PMID: 17308855 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10326531 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15863948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18305998 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18958517 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18449595 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18311576 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19177420 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22005150 (View on PubMed)

Other Identifiers

BBN/501/ZKL/87/L

Identifier Type: -

Identifier Source: org_study_id