A Prospective Randomized Equivalence Trial to Evaluate the Safety of the Ligasure in Thyroid Surgery

NCT01163565 | Completed DMC

• 1 other identifier: Pro00004394
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, prospective equivalence trial on the safety of the Ligasure Vessel Sealing System as used in thyroid surgery. The Ligasure system is a hand held surgical device that uses heat to seal blood vessels during surgery. It has been a tested and accepted technology in abdominal surgery and it is now being applied to surgery of the thyroid gland because it is faster than the traditional method of tying blood vessels that a surgeon must do manually. To remove the thyroid gland safely the surgeon must dissect the gland away from the recurrent laryngeal nerve which controls the vocal cords and patient's voice. Protecting this nerve is the key step in all thyroid surgery as its damage can permanently alter a patient's voice and even obstruct the airway. At this time the worldwide accepted rate of nerve injury is 2 in 100 patients. The hypothesis of this study is that the nerve injury rates for surgery using the Ligasure device are similar to that seen when surgeons manually tie blood vessels. The investigators protocol will evaluate the function of the recurrent laryngeal nerve after removing the thyroid gland using the Ligasure device in comparison to the traditional method where the surgeon manually ties blood vessels. In this study, for patients undergoing total thyroidectomy for a benign condition, each patient will be randomized to have one lobe of thyroid (left or right) removed using manual tying of blood vessels and the other side will have the surgeon use the Ligasure device to seal blood vessels. Every patient has a pre- and post-operative independent assessment of vocal cord function using nasopharyngoscopy to ensure that the vocal cords are working normally prior to surgery and also to document vocal cord dysfunction if there is an injury to the recurrent laryngeal nerve. The investigators intent is to show that the Ligasure system is a safe method to sealing vessels in thyroid surgery and that the thermal dispersion of this device does not pose a significant increase in risk to the recurrent laryngeal nerve

Conditions

Multinodular Goitre; Grave's Disease; Thyroid Nodule

Keywords

Thyroidectomy

Outcome Measures

Primary Outcomes (1)

• recurrent laryngeal nerve injury

  6 months

Study Arms (2)

Ligasure device

ACTIVE COMPARATOR

Device: Ligasure Device

Hand ties

NO INTERVENTION

Interventions

Ligasure Device DEVICE

Ligasure device used to seal blood vessels during left or right side of a total thyroidectomy. Traditional method of hand ties/clips on contralateral side.

Ligasure device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• multinodular goiter
• Grave's disease
• thyroid nodule

You may not qualify if:

• thyroid carcinoma
• reoperative surgery

Sponsors & Collaborators

• University of Alberta: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Walter C Mackenzie Health Sciences Centre

Edmonton, Alberta, T6G 2B6, Canada

Location

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 15, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

CA (1)