Subtotal Versus Total Thyroidectomy for Benign Goiter
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Goiter |
Procedure: thyroid resection |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Subtotal Versus Total Thyroidectomy for Benign Thyroid Disease - a Prospective Case-control Surgical Outcome Study. |
- Primary outcome measure was the prevalence of recurrent goiter, incidental thyroid cancer and need for revision thyroid surgery. [ Time Frame: folow-up at yearly intervals following thyroidectomy ] [ Designated as safety issue: No ]
- Secondary outcome measure was the postoperative morbidity rate (hypoparathyroidism, recurrent laryngeal nerve injury and bleeding). [ Time Frame: 12-month follow-up after thyroidectomy ] [ Designated as safety issue: Yes ]
| Enrollment: | 8006 |
| Study Start Date: | January 1999 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: BST
bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each)
|
Procedure: thyroid resection
bilateral subtotal versus total thyroidectomy
|
|
Experimental: TT
extracapsular total thyroidectomy
|
Procedure: thyroid resection
bilateral subtotal versus total thyroidectomy
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Poland | |
| Jagiellonian Univerity, Medical College, 3rd Department of general Surgery | |
| Krakow, Malopolska, Poland, 31-202 | |
| Principal Investigator: | Marcin Barczynski, MD, PhD | Jagiellonian University, Medical College |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT01273714 History of Changes |
| Other Study ID Numbers: | BBN/501/ZKL/87/L |
| Study First Received: | January 7, 2011 |
| Last Updated: | January 7, 2011 |
| Health Authority: | Poland: Ministry of Health |
Keywords provided by Jagiellonian University:
|
benign thyroid disease incidental thyroid cancer recurrent goiter revision thyroid surgery |
Additional relevant MeSH terms:
|
Goiter Thyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013