NCT03773120

Brief Summary

The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

April 6, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2019

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

April 12, 2018

Last Update Submit

January 13, 2022

Conditions

Carcinoma, Papillary, Follicular

Keywords

superior laryngeal nerve

Outcome Measures

Primary Outcomes (1)

  • Identification of EBSLN during thyroid surgery

    Identification rate of EBSLN

    up to postoperative 12 months

Secondary Outcomes (2)

  • Location of EBSLN

    up to postoperative 12 months

  • Vocal outcome

    up to postoperative 12 months

Study Arms (2)

Using Neuromonitoring to find EBSLN

EXPERIMENTAL

With Neuromonitoring of the EBSLN using nerve monitoring system

Device: Using Neuromonitoring to find EBSLN

No Using Neuromonitoring to find EBSLN

NO INTERVENTION

Without Neuromonitoring of the EBSLN using nerve monitoring system

Interventions

Using Neuromonitoring to find EBSLNDEVICE

intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery

Using Neuromonitoring to find EBSLN

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • planned open thyroidectomy
  • acceptable clinical laboratory tests
  • understand clinical trials
  • no significant past medical history

You may not qualify if:

  • planned radical neck dissection
  • hyperthyroidism history
  • history of laryngeal nerve palsy
  • laryngeal disease history
  • uncontrolled hypertension or diabetes mellitus or heart disease
  • anticoagulation or antiplatelet medication
  • stroke history
  • participated another clinical trials in 30days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Papillary, Follicular

Condition Hierarchy (Ancestors)

Adenocarcinoma, FollicularAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsAdenocarcinoma, Papillary

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 12, 2018

First Posted

December 12, 2018

Study Start

April 6, 2018

Primary Completion

July 23, 2019

Study Completion

July 23, 2019

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations

KR(1)