NCT06573268

Brief Summary

One year comparative analysis between SPRA\* versus BABA\*\* thyroid surgery. \* SPRA: da-Vinci SP Robotic Areolar approach thyroid surgery \*\* BABA: da-Vinci Xi robotic Bilateral. Axillary Breast Approach thyroid surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

August 16, 2024

Last Update Submit

August 25, 2024

Conditions

Thyroid CancerThyroid Nodule

Keywords

thyroidrobotic surgical proceduresminimally invasive surgical procedures

Outcome Measures

Primary Outcomes (1)

  • Total operation time (minutes)

    Time for spending total surgery

    on the surgery day (1 day)

Secondary Outcomes (1)

  • Hospital stay days after surgery

    after the surgery day (up to 2 weeks)

Study Arms (2)

SPRA

patients who received da-Vinci SP robot thyroid surgery by SPRA method (Single Port Robotic Areolar)

Device: robot surgery device

BABA

patients who received da-Vinci SP robot thyroid surgery by BABA method (Bilateral Axillary Breast Approach)

Device: robot surgery device

Interventions

robot surgery deviceDEVICE

SPRA used da-Vinci SP system (SPRA) BABA used da-Vinci Xi system (BABA)

BABASPRA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received robot thyroid surgery in our institution during study period

You may qualify if:

  • Patients who received robot thyroid surgery in our institution
  • Retrospective review

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University Hospital

Incheon, 22332, South Korea

Location

Related Publications (2)

  • Choi YS, Choi JH, Jeon MS, Yu MJ, Lee HM, Shin AY, Yi JW. First Experience of Single-Port Robotic Areolar Approach Thyroidectomy. Clin Exp Otorhinolaryngol. 2023 Aug;16(3):275-281. doi: 10.21053/ceo.2023.00682. Epub 2023 Jul 5.

    PMID: 37475141RESULT

  • Choi YS, Shin WY, Yi JW. Single Surgeon Experience with 500 Cases of the Robotic Bilateral Axillary Breast Approach (BABA) for Thyroid Surgery Using the Da-Vinci Xi System. J Clin Med. 2021 Sep 7;10(18):4048. doi: 10.3390/jcm10184048.

    PMID: 34575159RESULT

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid NoduleThyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 27, 2024

Study Start

December 1, 2022

Primary Completion

December 31, 2023

Study Completion

August 1, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)