Da-vinci sp Versus xi Thyroid Surgery

August 25, 2024 updated by: Jin Wook Yi, Inha University Hospital

One-year Clinical Experiences of Single-port and Multi-port Robotic Thyroid Surgery in Single Institution

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design: retrospective data analysis Study period: December 2022 to December 2023 Candidate: Patients who received robot thyroid surgery during study period Numbers of candidates: total of 270 patients Group : SPRA (n=111) versus BABA (n=159) Statistic analysis: t-test for continuous variable, fisher's exact test for categorical variable

Study Type

Observational

Enrollment (Actual)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SPRA
patients who received da-Vinci SP robot thyroid surgery by SPRA method (Single Port Robotic Areolar)
Device: robot surgery device
SPRA used da-Vinci SP system (SPRA) BABA used da-Vinci Xi system (BABA)
BABA
patients who received da-Vinci SP robot thyroid surgery by BABA method (Bilateral Axillary Breast Approach)
Device: robot surgery device
SPRA used da-Vinci SP system (SPRA) BABA used da-Vinci Xi system (BABA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total operation time (minutes)
Time Frame: on the surgery day (1 day)
Time for spending total surgery
on the surgery day (1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay days after surgery
Time Frame: after the surgery day (up to 2 weeks)
Hospital admission days after surgery
after the surgery day (up to 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inha University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 25, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-08-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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