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

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ClinicalTrials.gov Identifier: NCT03922282
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dongsik Bae, Inje University

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 .

Condition or disease Intervention/treatment Phase
Thyroidectomy Thyroid Diseases Procedure: Gasless BABA Procedure: Classic BABA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, and Controlled Study of the Safety and Efficacy in Gasless BABA(Bilateral Axillo-breast Approach) Robotic Thyroidectomy
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : October 8, 2018

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.




Primary Outcome Measures :
  1. heart rate [ Time Frame: Change from baseline heart rate at the end of surgery ]
    heart rate in beats per minute

  2. mean arterial pressure [ Time Frame: Change from baseline mean arterial pressure at the end of surgery ]
    mean arterial pressure in mmHg

  3. cardiac index [ Time Frame: Change from baseline cardiac index at the end of surgery ]
    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

  4. cardiac output [ Time Frame: Change from baseline cardiac output at the end of surgery ]
    cardiac output in L/minute, calculated by multiplying the stroke volume by the heart rate, measured by the Vigileo monitor

  5. pH [ Time Frame: Change from baseline pH at the end of surgery ]
    pH

  6. PaCO2 [ Time Frame: Change from baseline PaCO2 at the end of surgery ]
    PaCO2 in mmHg

  7. VAS(visual analog score) [ Time Frame: change from baseline VAS up to 3days after surgery ]
    Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains

  8. BHC(bottom hit count) [ Time Frame: change from baseline BHC up to 3days after surgery ]
    bottom hit count from intravenous patient controlled analgesia for pain

  9. number of analgesics [ Time Frame: change from baseline number of analgesics up to 3days after surgery ]
    number of analgesics(additional ketorolac uses)



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Ages Eligible for Study:   19 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922282


Locations
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Korea, Republic of
Dong sik Bae
Busan, Korea, Republic of
Sponsors and Collaborators
Inje University

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Responsible Party: Dongsik Bae, Assistant Professor, Inje University
ClinicalTrials.gov Identifier: NCT03922282     History of Changes
Other Study ID Numbers: 2017-08-009-004
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dongsik Bae, Inje University:
Gasless
Bilateral axillo-breast approach
Da Vinci
Robot-assisted thyroid surgery

Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases