Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

NCT ID: NCT00946894

Last Updated: 2009-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2008-12-31

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.

Conditions

Goiter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Total thyroidectomy

Patients who underwent total thyroidectomy

Group Type: EXPERIMENTAL

Total thyroidectomy

Intervention Type: PROCEDURE

Total thyroidectomy

Dunhill operation

Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy

Group Type: EXPERIMENTAL

Dunhill operation

Intervention Type: PROCEDURE

Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy

Bilateral subtotal thyroidectomy

Patients who underwent bilateral subtotal thyroidectomy

Group Type: ACTIVE_COMPARATOR

Bilateral subtotal thyroidectomy

Intervention Type: PROCEDURE

Bilateral subtotal thyroidectomy

Interventions

Total thyroidectomy

Total thyroidectomy

Intervention Type: PROCEDURE

Dunhill operation

Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy

Intervention Type: PROCEDURE

Bilateral subtotal thyroidectomy

Bilateral subtotal thyroidectomy

Intervention Type: PROCEDURE

Other Intervention Names

TT; DO; BST

Eligibility Criteria

Inclusion Criteria

• 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.

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

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Jagiellonian University Medical College

Principal Investigators

Marcin Barczynski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University College of Medicine

Locations

Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery

Krakow, , 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, 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.

Reference Type: DERIVED

PMID: 28942461 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20174803 (View on PubMed)

Other Identifiers

BBN/501/ZKL/68/L

Identifier Type: -

Identifier Source: org_study_id