Subtotal Versus Total Thyroidectomy for Graves' Disease

August 2, 2011 updated by: Jagiellonian University

Five-year Follow up of a Randomized Clinical Trial of Bilateral Subtotal Thyroidectomy Versus Total Thyroidectomy for Graves' Disease.

The extent of thyroid resection in Graves' disease remains controversial. The aim of this study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total thyroidectomy in patients with Graves' ophthalmopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Graves' disease was first described in 1835. It is an autoimmune disorder caused by antibodies which bind to thyroid-stimulating hormone (TSH) receptors on the thyroid cell membrane. The overt clinical manifestation of this disease is usually characterised by presence of hyperthyroidism, thyroid associated ophthalmopathy and thyroid dermopathy.

Treatment alternatives of Graves' disease include antithyroid medication, radioiodine therapy or thyroidectomy. The antithyroid medication is often used as the initial treatment for patients with newly diagnosed Graves disease in much of the world including Europe, Japan and South America. However, the use of radioiodine is the most common first-line treatment modality in the United States. Thyroidectomy should be considered in special circumstances such as in children and young adults, pregnant women, in the setting of ophthalmopathy, in the presence of thyroid nodules or big goitre, particularly when compressive symptoms, or substernal thyroid extension is diagnosed, as well as in cases of failed hyperthyroidism remission after antithyroid medication in patients refusing possible radioiodine treatment.

The surgical management of Graves' disease remains controversial. Some authors support total thyroidectomy while others prefer various subtotal procedures. Most low-volume surgeons avoid performing total thyroidectomies for Graves' disease owing to the assumed higher complication rates. On the other hand, an increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indications for this procedure include not only high-risk thyroid cancer, but also Graves's disease and multinodular goiter. It has been shown that total thyroidectomy for Graves' disease lowers to almost zero the disease recurrence rate. However, other issues like unclear benefit for natural course of Graves' ophthalmopathy balanced against assumed higher risk of morbidity following more radical thyroid resections need to be clarified.

We hypothesized that total thyroidectomy is superior to bilateral subtotal thyroidectomy for long-term control of Graves' disease. The aim of this study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total thyroidectomy in patients with mild and active Graves' ophthalmopathy.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Krakow, Poland, 31-202
        • Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • planned thyroid surgery for clinically, biochemically and immunologically diagnosed Graves' disease in patients with mild active ophthalmopathy and the posterior aspects of both thyroid lobes appearing normal on ultrasound of the neck.

Exclusion Criteria:

  • previous thyroid or parathyroid surgery,
  • recurrent hyperthyroidism after radioiodine ablation,
  • history of Graves' disease longer than 24 months,
  • thyroid nodules within the posterior aspect/s of thyroid lobe/s,
  • suspicion of thyroid cancer,
  • inactive Graves' ophthalmopathy,
  • moderate to severe active Graves' ophthalmopathy,
  • preoperative recurrent laryngeal nerve palsy,
  • pregnancy or lactation,
  • age < 18 years, or > 65 years,
  • ASA 4 grade (American Society of Anaesthesiology),
  • inability to comply with the follow-up protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bilateral subtotal thyroidectomy
Procedure: Bilateral subtotal thyroidectomy
The intervention consisted of bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each).
Other Names:
  • BST
Experimental: Total thyroidectomy
Procedure: Total thyroidectomy
The intervention consisted of total extracapsular thyroidectomy.
Other Names:
  • TT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term control of Graves' disease
Time Frame: up to 60 months postoperatively
Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy
up to 60 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity rate
Time Frame: up to 12 months postoperatively
recurrent laryngeal nerve injury and hypoparathyroidism
up to 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBN/501/ZKL/67/L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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