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OpenTrials
Completed

NCT Number: NCT01273714

Subtotal Versus Total Thyroidectomy for Benign Goiter

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.

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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 Univerity, Medical College, 3rd Department of general Surgery

Krakow, Malopolska, 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 small prospective 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 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.

Treatment and study plan

thyroid resection

Procedure

bilateral subtotal versus total thyroidectomy

Primary outcomes

  1. 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

Secondary outcomes

  1. Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding).

    Time frame: 12-month follow-up after thyroidectomy

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Subtotal Versus Total Thyroidectomy for Benign Thyroid Disease - a Prospective Case-control Surgical Outcome Study.

Important dates

Study start
1999
Primary completion
2004
Study completion
2009
First posted
Jan 10, 2011
Registry last updated
Jan 10, 2011

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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