Subtotal Versus Total Thyroidectomy for Benign Goiter

Sponsor
Jagiellonian University (Other)
Overall Status
Completed
CT.gov ID
NCT01273714
Collaborator
(none)
8,006
1
2
131
61.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: thyroid resection
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
8006 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Subtotal Versus Total Thyroidectomy for Benign Thyroid Disease - a Prospective Case-control Surgical Outcome Study.
Study Start Date :
Jan 1, 1999
Actual Primary Completion Date :
Dec 1, 2004
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Primary outcome measure was the prevalence of recurrent goiter, incidental thyroid cancer and need for revision thyroid surgery. [folow-up at yearly intervals following thyroidectomy]

Secondary Outcome Measures

  1. Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding). [12-month follow-up after thyroidectomy]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01273714
Other Study ID Numbers:
  • BBN/501/ZKL/87/L
First Posted:
Jan 10, 2011
Last Update Posted:
Jan 10, 2011
Last Verified:
Jan 1, 2011

Study Results

No Results Posted as of Jan 10, 2011