Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

July 24, 2009 updated by: Jagiellonian University

Five-year Follow up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 prospective randomized studies comparing the outcomes of total vs. subtotal thyroidectomy.

Study Type

Interventional

Enrollment (Actual)

600

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total thyroidectomy
Patients who underwent total thyroidectomy
Procedure: Total thyroidectomy
Total thyroidectomy
Other Names:
  • TT
Experimental: Dunhill operation
Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
Procedure: Dunhill operation
Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
Other Names:
  • DO
Active Comparator: Bilateral subtotal thyroidectomy
Patients who underwent bilateral subtotal thyroidectomy
Procedure: Bilateral subtotal thyroidectomy
Bilateral subtotal thyroidectomy
Other Names:
  • BST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at 12, 24, 36, 48 and 60 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery

Collaborators and Investigators

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

Sponsor

Jagiellonian University

Investigators

  • Principal Investigator: Marcin Barczynski, MD, PhD, Jagiellonian University College of Medicine

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, 2003

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

July 27, 2009

Last Update Submitted That Met QC Criteria

July 24, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBN/501/ZKL/68/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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