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Completed

NCT Number: NCT00946894

Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Krakow, 31-202, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total thyroidectomy

Procedure

Total thyroidectomy

Other names: TT

Dunhill operation

Procedure

Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy

Other names: DO

Bilateral subtotal thyroidectomy

Procedure

Bilateral subtotal thyroidectomy

Other names: BST

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study 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.

Important dates

Study start
2000
Primary completion
2003
Study completion
2008
First posted
Jul 27, 2009
Registry last updated
Jul 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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