Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

Not Applicable

Completed

• Conditions: Goiter
• Interventions: Procedure: Total thyroidectomy; Procedure: Dunhill operation; Procedure: Bilateral subtotal thyroidectomy

• Registration Number: NCT00946894
• Lead Sponsor: Jagiellonian University

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 Timeline

• Study Start: 2000-01
• Primary Completion: 2003-12
• Study Completion: 2008-12
• Status Verified: 2009-07
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-24
• Last Update Submitted: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Posted: 2009-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total thyroidectomy	Total thyroidectomy	Patients who underwent total thyroidectomy
Dunhill operation	Dunhill operation	Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
Bilateral subtotal thyroidectomy	Bilateral subtotal thyroidectomy	Patients who underwent bilateral subtotal thyroidectomy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery; 🇵🇱 Krakow, Poland