Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

NCT ID: NCT01163045

Last Updated: 2010-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-01-31

Brief 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.

Detailed 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.

Conditions

Thyroidectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

neuromonitoring and neurostimulation

Group Type: EXPERIMENTAL

thyroidectomy

Intervention Type: PROCEDURE

total thyroidectomy and lobectomy

neurostimulation of recurrent laryngeal nerve

Group Type: EXPERIMENTAL

thyroidectomy

Intervention Type: PROCEDURE

total thyroidectomy and lobectomy

Interventions

thyroidectomy

total thyroidectomy and lobectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

ENT Clinic Policlinico S.Orsola-Malpighi Bologna, Italy

Principal Investigators

Ottavio O Cavicchi, MD

Role: STUDY_DIRECTOR

ENT Clinic Ploiclinico S.Orsola-Malpighi Bologna Italy

Locations

Policlinico S.Orsola-Malpighi ENT Clini University of Bologna Italy

Bologna, Italy/Bologna, Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 19177420 (View on PubMed)

Cavicchi O, Caliceti U, Fernandez IJ, Ceroni AR, Marcantoni A, Sciascia S, Sottili S, Piccin O. Laryngeal neuromonitoring and neurostimulation versus neurostimulation alone in thyroid surgery: a randomized clinical trial. Head Neck. 2012 Feb;34(2):141-5. doi: 10.1002/hed.21681. Epub 2011 Apr 5.

Reference Type: DERIVED

PMID: 21469244 (View on PubMed)

Other Identifiers

2 - Cavicchi

Identifier Type: -

Identifier Source: org_study_id