Subtotal Versus Total Thyroidectomy for Benign Goiter

Not Applicable

Completed

• Conditions: Goiter
• Interventions: Procedure: thyroid resection

• Registration Number: NCT01273714
• Lead Sponsor: Jagiellonian University

Brief Summary

The extent of thyroid resection in benign goiter is controversial. Potential advantages of TT over BST may include: one-stage removal of incidental thyroid cancer reported in up to 10% of operatively treated benign thyroid diseases, and lower risk for goiter recurrence. However, these potential advantages should outweigh the risk of morbidity associated with more radical thyroid resection.

The aim of this study was to compare outcomes of bilateral subtotal (BST) vs. total thyroidectomy (TT) for benign bilateral thyroid disease.

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

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2004-12
• Study Completion: 2009-12
• Status Verified: 2011-01
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-07
• Last Update Submitted: 2011-01-07
• Study First Posted: 2011-01-10
• Last Update Posted: 2011-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8006

Inclusion Criteria

• a benign bilateral thyroid disease with the posterior aspects of both thyroid lobes appearing normal on ultrasound of the neck.

Exclusion Criteria

• thyroid disease involving the posterior aspect/s of thyroid lobe/s,
• suspicion of thyroid cancer,
• previous thyroid surgery,
• pregnancy or lactation,
• age < 18 years or > 65 years,
• ASA 4 grade (American Society of Anesthesiology),
• and inability to comply with the follow-up protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TT	thyroid resection	extracapsular total thyroidectomy
BST	thyroid resection	bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each)

Primary Outcome Measures

Name	Time	Method
Primary outcome measure was the prevalence of recurrent goiter, incidental thyroid cancer and need for revision thyroid surgery.	folow-up at yearly intervals following thyroidectomy

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding).	12-month follow-up after thyroidectomy

Trial Locations

Locations (1)

Jagiellonian Univerity, Medical College, 3rd Department of general Surgery; 🇵🇱 Krakow, Malopolska, Poland