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

Inje University

Status: Completed

Conditions: Thyroid Diseases; Thyroidectomy

Treatments: Procedure: Gasless BABA; Procedure: Classic BABA

Study type: Interventional

Funder types: Other

Identifiers

NCT03922282

2017-08-009-004

Details and patient eligibility

About

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 .

Enrollment: 28 patients

Sex: All

Ages: 19 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups

Gasless BABA

Experimental group

Description:

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

Treatment:

Procedure: Gasless BABA

Classic BABA

Active Comparator group

Description:

BABA robotic-thyroidectomy using carbon dioxide.

Treatment:

Procedure: Classic BABA