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Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial


N/A
18 Years
N/A
Open (Enrolling)
Both
Indeterminate Thyroid Nodules

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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

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