Subtotal Versus Total Thyroidectomy for Benign Goiter

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT01273714
First received: January 7, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Goiter
Procedure: thyroid resection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subtotal Versus Total Thyroidectomy for Benign Thyroid Disease - a Prospective Case-control Surgical Outcome Study.

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • Primary outcome measure was the prevalence of recurrent goiter, incidental thyroid cancer and need for revision thyroid surgery. [ Time Frame: folow-up at yearly intervals following thyroidectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding). [ Time Frame: 12-month follow-up after thyroidectomy ] [ Designated as safety issue: Yes ]

Enrollment: 8006
Study Start Date: January 1999
Study Completion Date: December 2009
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BST
bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each)
Procedure: thyroid resection
bilateral subtotal versus total thyroidectomy
Experimental: TT
extracapsular total thyroidectomy
Procedure: thyroid resection
bilateral subtotal versus total 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 small prospective 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 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01273714

Locations
Poland
Jagiellonian Univerity, Medical College, 3rd Department of general Surgery
Krakow, Malopolska, Poland, 31-202
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Marcin Barczynski, MD, PhD Jagiellonian University, Medical College
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01273714     History of Changes
Other Study ID Numbers: BBN/501/ZKL/87/L
Study First Received: January 7, 2011
Last Updated: January 7, 2011
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
benign thyroid disease
incidental thyroid cancer
recurrent goiter
revision thyroid surgery

Additional relevant MeSH terms:
Goiter
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014