BABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas

NCT ID: NCT03922282

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2018-10-08

Brief Summary

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In this study, a randomized controlled study was conducted between two groups of 14 classic recipients of Carbon dioxide insufflation during BABA robotic-thyroidectomy and 14 recipients of Gasless method during BABA robotic-thyroidectomy. This is a study to see if there is any difference in hemodynamic and metabolic changes and pain .

Detailed Description

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Conditions

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Thyroidectomy Thyroid Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Gasless BABA

BABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap.

Group Type EXPERIMENTAL

Gasless BABA

Intervention Type PROCEDURE

BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.

Classic BABA

BABA robotic-thyroidectomy using carbon dioxide.

Group Type ACTIVE_COMPARATOR

Classic BABA

Intervention Type PROCEDURE

BABA robotic-thyroidectomy that is using carbon dioxide.

Interventions

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Gasless BABA

BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.

Intervention Type PROCEDURE

Classic BABA

BABA robotic-thyroidectomy that is using carbon dioxide.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subject who will have thyroid surgery

Exclusion Criteria

* Subject who underwent thyroid surgery
* Subject who underwent any radiotherapy on neck
* Subject who need to neck dissection
* Subject under 18 years or over 70 years
* Bad general condition
* High American Society of Anesthesiologists(ASA) score (over 3)
* Breast feeder or pregnancy
* Subject who disagree to do this trial
Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Dongsik Bae

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dong sik Bae

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2017-08-009-004

Identifier Type: -

Identifier Source: org_study_id

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