Trial Information
Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial
Inclusion Criteria:
- Indeterminate or benign pathology on fine needle aspirate biopsy
- Scheduled to undergo total or hemi-thyroidectomy
- > 18 years old
Exclusion Criteria:
- Previous thyroid surgery
- Previous neck surgery in field of thyroidectomy
- Previous neck irradiation
- Pre-operative hypocalcemia or hypoparathyroidism
- Biopsy suggestive of thyroid cancer
- Neck nodes suspicious for or with known cancer
- Pre-operative vocal cord dysfunction
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Short Term Hypo-calcemia
Outcome Description:
Definition: Serum Ionized Calcium (ICa) < 0.9 mmol/L or symptoms related to hypocalcemia (acral or peri-oral paresthesia/numbess, tetany, muscle cramps/twitching, delirium etc.) and ICa < 1.0 mmol/L
Outcome Time Frame:
< 1 month post-operatively
Safety Issue:
Yes
Principal Investigator
Peter T Dziegielewski, MD
Investigator Role:
Study Director
Investigator Affiliation:
University of Alberta
Authority:
Canada: Ethics Review Committee
Study ID:
88888
NCT ID:
NCT01106443
Start Date:
February 2010
Completion Date:
December 2013
Related Keywords:
- Indeterminate Thyroid Nodules
- Indeterminate thyroid nodule
- fine needle aspirate biopsy
- thyroidectomy
- central lymph node dissection
- Thyroid Nodule