Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946894
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : July 27, 2009
Information provided by:
Jagiellonian University

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.

Condition or disease Intervention/treatment
Goiter Procedure: Total thyroidectomy Procedure: Dunhill operation Procedure: Bilateral subtotal thyroidectomy

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : January 2000
Primary Completion Date : December 2003
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Total thyroidectomy
Patients who underwent total thyroidectomy
Procedure: Total thyroidectomy
Total thyroidectomy
Other Name: TT
Experimental: Dunhill operation
Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
Procedure: Dunhill operation
Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
Other Name: DO
Active Comparator: Bilateral subtotal thyroidectomy
Patients who underwent bilateral subtotal thyroidectomy
Procedure: Bilateral subtotal thyroidectomy
Bilateral subtotal thyroidectomy
Other Name: BST

Primary Outcome Measures :
  1. Primary outcome measure was prevalence of recurrent goiter and need for redo surgery. [ Time Frame: at 12, 24, 36, 48 and 60 months after surgery ]

Secondary Outcome Measures :
  1. Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury). [ Time Frame: at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946894

Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
Krakow, Poland, 31-202
Sponsors and Collaborators
Jagiellonian University
Principal Investigator: Marcin Barczynski, MD, PhD Jagiellonian University College of Medicine


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Piotr Laider / Head of the Biomedical Research Committee of the Jagiellonian University, Jagiellonian University Medical College Identifier: NCT00946894     History of Changes
Other Study ID Numbers: BBN/501/ZKL/68/L
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: July 27, 2009
Last Verified: July 2009

Keywords provided by Jagiellonian University:
Total thyroidectomy
Subtotal thyroidectomy
Dunhill operation
Recurrent nodular goiter
Completion thyroidectomy
Recurrent laryngeal nerve palsy
Hypoparathyroidism following thyroidectomy
Recurrent goiter

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases