Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

Thyroidectomy Clinical Trial

Official title:

Intraoperative Neuromonitoring and Neurostimulation of the Recurrent Laryngeal Nerve Versus Neurostimulation Alone in Thyroid Surgery: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163045
• Other study ID #: 2 - Cavicchi
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2010
• Last updated: July 14, 2010
• Start date: January 2008
• Est. completion date: January 2010

Study information

• Verified date: June 2010
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate if intraoperative neuromonitoring associated to neurostimulation of recurrent laryngeal nerve reduce the rate of recurrent laryngeal palsy respect to neurostimulation alone.

Description:

Anatomic and functional preservation of the recurrent laryngeal nerve is a key element of thyroid surgery. Surgical exposure and visual identification of the nerve during thyroid surgery has been shown to provide the best rates of normal postoperative vocal fold function. Nevertheless, identification of the nerve sometimes can be difficult in patients who are heavily scarred or who have undergone previous surgery. Moreover, an anatomical intact nerve does not always correlate with normal vocal fold function. So it is mandatory to identify the nerve and to establish its function. Two techniques are described to facilitate identification of the nerve and to test its function. One is the neurostimulation with laryngeal palpation which is an intermittent monitoring techniques that permits to evaluate the contraction of cricoarytenoid muscle (laryngeal twitch ) after stimulation of RLN or vagal nerve with an electric stimulator probe. More recently some authors have suggested a continuous intraoperative neuromonitoring which provide audio and visual feed back when the nerve is electrically or mechanically stimulated during thyroidectomy. However controversy remains as to whether intraoperative neuromonitoring confers any significant benefit in injury prevention of recurrent laryngeal nerve.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

Inclusion Criteria:

• Mono or bilateral thyroid surgery

Exclusion Criteria:

• Previous thyroid and parathyroid surgery

• Thyroidectomy with mono or bilateral neck dissection

• Extended thyroidectomy for locally advanced thyroid carcinoma

• Retrosternal goitre

• Minimally invasive thyroid surgery

• Preoperative palsy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroidectomy

Intervention

Procedure:
• thyroidectomy
total thyroidectomy and lobectomy

Locations

Country	Name	City	State
Italy	Policlinico S.Orsola-Malpighi ENT Clini University of Bologna Italy	Bologna	Italy/Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Barczynski M, Konturek A, Cichon S. Randomized clinical trial of visualization versus neuromonitoring of recurrent laryngeal nerves during thyroidectomy. Br J Surg. 2009 Mar;96(3):240-6. doi: 10.1002/bjs.6417. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent laryngeal nerve paralysis			Yes