NCT01163045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
Last Updated

July 15, 2010

Status Verified

June 1, 2010

Enrollment Period

1.1 years

First QC Date

July 13, 2010

Last Update Submit

July 14, 2010

Conditions

Thyroidectomy

Keywords

neurostimulationintraoperative neuromonitoringrecurrent laryngeal nervepalsy of recurrent laryngeal nerveRCT

Outcome Measures

Primary Outcomes (1)

  • recurrent laryngeal nerve paralysis

Study Arms (2)

neuromonitoring and neurostimulation

EXPERIMENTAL
Procedure: thyroidectomy

neurostimulation of recurrent laryngeal nerve

EXPERIMENTAL
Procedure: thyroidectomy

Interventions

thyroidectomyPROCEDURE

total thyroidectomy and lobectomy

neuromonitoring and neurostimulationneurostimulation of recurrent laryngeal nerve

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mono or bilateral thyroid surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, Italy/Bologna, 40100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 19177420RESULT

  • 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.

    PMID: 21469244DERIVED

MeSH Terms

Interventions

Thyroidectomy

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ottavio O Cavicchi, MD

    ENT Clinic Ploiclinico S.Orsola-Malpighi Bologna Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 15, 2010

Study Start

January 1, 2008

Primary Completion

February 1, 2009

Study Completion

January 1, 2010

Last Updated

July 15, 2010

Record last verified: 2010-06

Locations

IT(1)