Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

This study has been completed.

Sponsor:

Information provided by:

Jagiellonian University

ClinicalTrials.gov Identifier:

NCT00946894

First received: July 23, 2009

Last updated: July 24, 2009

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 23, 2009

Last Updated Date

July 24, 2009

Start Date ^ICMJE

January 2000

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00946894 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

Official Title ^ICMJE

Five-year Follow up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter.

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Goiter

Intervention ^ICMJE

Procedure: Total thyroidectomy
Total thyroidectomy

Other Name: TT
Procedure: Dunhill operation
Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy

Other Name: DO
Procedure: Bilateral subtotal thyroidectomy
Bilateral subtotal thyroidectomy

Other Name: BST

Study Arm (s)

Experimental: Total thyroidectomy
Patients who underwent total thyroidectomy

Intervention: Procedure: Total thyroidectomy
Experimental: Dunhill operation
Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy

Intervention: Procedure: Dunhill operation
Active Comparator: Bilateral subtotal thyroidectomy
Patients who underwent bilateral subtotal thyroidectomy

Intervention: Procedure: Bilateral subtotal thyroidectomy

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

600

Completion Date

December 2008

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00946894

Other Study ID Numbers ^ICMJE

BBN/501/ZKL/68/L

Has Data Monitoring Committee

Yes

Responsible Party

Piotr Laider / Head of the Biomedical Research Committee of the Jagiellonian University, Jagiellonian University Medical College

Study Sponsor ^ICMJE

Jagiellonian University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marcin Barczynski, MD, PhD

Jagiellonian University College of Medicine

Information Provided By

Jagiellonian University

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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