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Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT00946894
First received: July 23, 2009
Last updated: July 24, 2009
Last verified: July 2009
History of Changes
  Purpose

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 Intervention
Goiter
 Procedure: Total thyroidectomy
Procedure: Dunhill operation
Procedure: Bilateral subtotal thyroidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 600
Study Start Date: January 2000
Study Completion Date: December 2008
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946894

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Piotr Laider / Head of the Biomedical Research Committee of the Jagiellonian University, Jagiellonian University Medical College
ClinicalTrials.gov Identifier: NCT00946894     History of Changes
Other Study ID Numbers: BBN/501/ZKL/68/L
Study First Received: July 23, 2009
Last Updated: July 24, 2009
Health Authority: Poland: Ministry of Health

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:
Goiter
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013