Back to resultsBABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas
Primary Purpose
Thyroidectomy, Thyroid Diseases
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gasless BABA
Classic BABA
Sponsored by
About this trial
This is an interventional treatment trial for Thyroidectomy focused on measuring Gasless, Bilateral axillo-breast approach, Da Vinci, Robot-assisted thyroid surgery
Eligibility Criteria
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
Sites / Locations
- Dong sik Bae
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gasless BABA
Classic BABA
Arm Description
BABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap.
BABA robotic-thyroidectomy using carbon dioxide.
Outcomes
Primary Outcome Measures
heart rate
heart rate in beats per minute
mean arterial pressure
mean arterial pressure in mmHg
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
cardiac output
cardiac output in L/minute, calculated by multiplying the stroke volume by the heart rate, measured by the Vigileo monitor
pH
pH
PaCO2
PaCO2 in mmHg
VAS(visual analog score)
Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains
BHC(bottom hit count)
bottom hit count from intravenous patient controlled analgesia for pain
number of analgesics
number of analgesics(additional ketorolac uses)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03922282
Brief Title
BABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas
Official Title
A Prospective, Randomized, and Controlled Study of the Safety and Efficacy in Gasless BABA(Bilateral Axillo-breast Approach) Robotic Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
October 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy, Thyroid Diseases
Keywords
Gasless, Bilateral axillo-breast approach, Da Vinci, Robot-assisted thyroid surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gasless BABA
Arm Type
Experimental
Arm Description
BABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap.
Arm Title
Classic BABA
Arm Type
Active Comparator
Arm Description
BABA robotic-thyroidectomy using carbon dioxide.
Intervention Type
Procedure
Intervention Name(s)
Gasless BABA
Intervention Description
BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.
Intervention Type
Procedure
Intervention Name(s)
Classic BABA
Intervention Description
BABA robotic-thyroidectomy that is using carbon dioxide.
Primary Outcome Measure Information:
Title
heart rate
Description
heart rate in beats per minute
Time Frame
Change from baseline heart rate at the end of surgery
Title
mean arterial pressure
Description
mean arterial pressure in mmHg
Time Frame
Change from baseline mean arterial pressure at the end of surgery
Title
cardiac index
Description
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
Time Frame
Change from baseline cardiac index at the end of surgery
Title
cardiac output
Description
cardiac output in L/minute, calculated by multiplying the stroke volume by the heart rate, measured by the Vigileo monitor
Time Frame
Change from baseline cardiac output at the end of surgery
Title
pH
Description
pH
Time Frame
Change from baseline pH at the end of surgery
Title
PaCO2
Description
PaCO2 in mmHg
Time Frame
Change from baseline PaCO2 at the end of surgery
Title
VAS(visual analog score)
Description
Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains
Time Frame
change from baseline VAS up to 3days after surgery
Title
BHC(bottom hit count)
Description
bottom hit count from intravenous patient controlled analgesia for pain
Time Frame
change from baseline BHC up to 3days after surgery
Title
number of analgesics
Description
number of analgesics(additional ketorolac uses)
Time Frame
change from baseline number of analgesics up to 3days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dong sik Bae
City
Busan
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
BABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas
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