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

A Prospective, Randomized, and Controlled Study of the Safety and Efficacy in Gasless BABA(Bilateral Axillo-breast Approach) Robotic Thyroidectomy

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 .

Study Overview

• Status: Completed
• Conditions: Thyroid Diseases; Thyroidectomy
• Intervention / Treatment: Procedure: Gasless BABA; Procedure: Classic BABA

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong sik Bae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gasless BABA; BABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap.	Procedure: Gasless BABA; BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.
Active Comparator: Classic BABA; BABA robotic-thyroidectomy using carbon dioxide.	Procedure: Classic BABA; BABA robotic-thyroidectomy that is using carbon dioxide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	heart rate in beats per minute	Change from baseline heart rate at the end of surgery
mean arterial pressure	mean arterial pressure in mmHg	Change from baseline mean arterial pressure at the end of surgery
cardiac index	cardiac index in L/min/m^2, divide the cardiac output by the person's body surface area, measured by the Vigileo monitor, normal range is 2.5 to 4.5L/min/m2	Change from baseline cardiac index at the end of surgery
cardiac output	cardiac output in L/minute, calculated by multiplying the stroke volume by the heart rate, measured by the Vigileo monitor	Change from baseline cardiac output at the end of surgery
pH	pH	Change from baseline pH at the end of surgery
PaCO2	PaCO2 in mmHg	Change from baseline PaCO2 at the end of surgery
VAS(visual analog score)	Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains	change from baseline VAS up to 3days after surgery
BHC(bottom hit count)	bottom hit count from intravenous patient controlled analgesia for pain	change from baseline BHC up to 3days after surgery
number of analgesics	number of analgesics(additional ketorolac uses)	change from baseline number of analgesics up to 3days after surgery

Collaborators and Investigators

• Sponsor: Inje University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): October 8, 2018

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Da Vinci; Gasless; Bilateral axillo-breast approach; Robot-assisted thyroid surgery
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: 2017-08-009-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No