Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Thyroidectomy |
Procedure: thyroidectomy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intraoperative Neuromonitoring and Neurostimulation of the Recurrent Laryngeal Nerve Versus Neurostimulation Alone in Thyroid Surgery: a Randomized Clinical Trial |
- recurrent laryngeal nerve paralysis [ Designated as safety issue: Yes ]
| Enrollment: | 250 |
| Study Start Date: | January 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: neuromonitoring and neurostimulation |
Procedure: thyroidectomy
total thyroidectomy and lobectomy
|
| Experimental: neurostimulation of recurrent laryngeal nerve |
Procedure: thyroidectomy
total thyroidectomy and lobectomy
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 84 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Italy | |
| Policlinico S.Orsola-Malpighi ENT Clini University of Bologna Italy | |
| Bologna, Italy/Bologna, Italy, 40100 | |
| Study Director: | Ottavio O Cavicchi, MD | ENT Clinic Ploiclinico S.Orsola-Malpighi Bologna Italy |
More Information
No publications provided by University of Bologna
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ottavio Cavicchi, ENT Clinic Policlinico S.Orsola-Malpighi Bologna, Italy |
| ClinicalTrials.gov Identifier: | NCT01163045 History of Changes |
| Other Study ID Numbers: | 2 - Cavicchi |
| Study First Received: | July 13, 2010 |
| Last Updated: | July 14, 2010 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Bologna:
|
neurostimulation intraoperative neuromonitoring recurrent laryngeal nerve palsy of recurrent laryngeal nerve RCT |
ClinicalTrials.gov processed this record on May 22, 2013