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Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves in Thyroid Surgery

NCT00661024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2008-04-18

No results posted yet for this study

Summary

Some recent studies have shown that intraoperative neuromonitoring (IONM) can aid the recurrent laryngeal nerve (RLN) identification during thyroid surgery. However, the role of IONM in reducing the incidence of RLN injury rate and the value of this method in predicting postoperative RLN function remain controversial. Only a few published series represent level III of evidence and grade C of recommendation according to the evidence-based criteria (Sackett's classification, modified by Heinrich). Thus, the aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thyroid surgery.

Conditions

  • Thyroid Surgery

Interventions

PROCEDURE

intraoperative RLN visualization

intraoperative RLN visualization

PROCEDURE

intraoperative neuromonitoring of the RLN

IONM

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Marcin Barczynski, MD, PhD · Jagiellonian University

  • Stanislaw Cichon, Prof, MD · Jagiellonian University

  • Aleksander Konturek, MD, PhD · Jagiellonian University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-06-30
Completion
2008-04-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00661024 on ClinicalTrials.gov