Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

Sponsor

Jagiellonian University (Other)

Overall Status

Completed

CT.gov ID

NCT00946894

Collaborator

(none)

600

Enrollment

Location

Arms

107

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Goiter	Procedure: Total thyroidectomy Procedure: Dunhill operation Procedure: Bilateral subtotal thyroidectomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official 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.

Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Total thyroidectomy

Patients who underwent total thyroidectomy

Procedure: Total thyroidectomy

Total thyroidectomy

Other Names:

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:

Active Comparator: Bilateral subtotal thyroidectomy

Patients who underwent bilateral subtotal thyroidectomy

Procedure: Bilateral subtotal thyroidectomy

Bilateral subtotal thyroidectomy

Other Names:

BST

Outcome Measures

Primary Outcome Measures

Primary outcome measure was prevalence of recurrent goiter and need for redo surgery. [at 12, 24, 36, 48 and 60 months after surgery]

Secondary Outcome Measures

Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury). [at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery]