NCT03907761

Brief Summary

This study evaluates the hydrodissection technique in recurrent laryngeal nerve (RLN) dissection in thyroid surgeries. In this study hydrodissection of RLN was performed routinely in thyroid surgeries.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

April 3, 2019

Last Update Submit

April 5, 2019

Conditions

Recurrent Laryngeal Nerve Injuries

Keywords

thyroidectomyrecurrent laryngeal nervehydrodissection

Outcome Measures

Primary Outcomes (1)

  • mobility of vocal cords preoperative to thyroid surgery

    to assess if there is RLN palsy prior thyroidectomy operation preoperative evaluation of vocal cords by indirect laryngoscopy were performed 3 days prior to surgery routinely.

    3 days before surgery

Secondary Outcomes (2)

  • mobility of vocal cords at the postoperative 3. day

    3 days after thyroidectomy

  • mobility of vocal cord at the injured side

    1 month after the operation

Interventions

HydrodissectionPROCEDURE

high velocity stream of normal saline is given to the dissection area by help of 10 ml syringe

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all the patients undergoing to thyroidectomy for thyroid nodules

You may qualify if:

  • \*patients undergoing thyroidectomy for various thyroid diseases

You may not qualify if:

  • \* patients in whom RLN palsy detected by indirect laryngoscopy before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Recurrent Laryngeal Nerve Injuries

Condition Hierarchy (Ancestors)

Laryngeal Nerve InjuriesLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve InjuriesCranial Nerve InjuriesCranial Nerve DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 9, 2019

Study Start

February 1, 2016

Primary Completion

August 31, 2017

Study Completion

December 31, 2018

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share