Cohort Study Comparing Surgeon Stress, Utilization of Surgical Instruments, Surgical Outcomes According to Surgical Approach for Gastrectomy

July 23, 2021 updated by: Yonsei University
A new surgical instrument is supposed to allow surgeon to do surgery with better performance. However, the learning period before getting used to the new instruments is necessary. The surgeon's stress to overcome the learning effect and the surgical outcome was rarely assessed. The comparative analysis of surgical outcome, surgeon's stress, and utilization of instruments for gastrectomy will be performed in prospective cohort study

Study Overview

Status

Recruiting

Conditions

Detailed Description

Before the surgery, all the eligible patients will be explained regarding the study and informed consent will be given. During the surgery, the surgeon will wear heart rate monitoring device to monitor hear rate variability of the surgeon. The surgical procedure will be recorded. After the surgery, morbidity following surgery will be monitored and recorded. At 1 month after surgery, additional morbidity will be recorded.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

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

Study Contact

  • Name: Hyoung-Il Kim
  • Phone Number: 82-2-2228-2095
  • Email: cairus@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Hyoung-Il Kim

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

No older than 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with gastric cancer scheduled to undergo gastrectomy in high volume center

Description

Inclusion Criteria:

Patients with gastric cancer scheduled for gastrectomy

Exclusion Criteria:

Vulnerable subject (illiterate, pregnant)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
LC
laparoscopic surgery using conventional laparoscopic instruments
LW
Using wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated grasper)
RC
Conventional robotic surgery
RSS
Use of single site system for reduced port robotic surgery
RSP
Use of da Vinci SP system for reduced port robotic surgery
RRI
A new surgical robot Revo-i developed by Meerae company in Korea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complication
Time Frame: 1 month after surgery
One of the most important surgical outcome, complication will be measured at 1 month after surgery
1 month after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
operative time (min)
Time Frame: 1 month after surgery
1 month after surgery
bleeding(ml)
Time Frame: 1 month after surgery
1 month after surgery
gas passing(day)
Time Frame: 1 month after surgery
1 month after surgery
hospital stay(day)
Time Frame: 1 month after surgery
1 month after surgery
readmission rate(percent)
Time Frame: 1 month after surgery
1 month after surgery
Heart rate variability of surgeon
Time Frame: during the operation
during the operation
Duration for each surgical instruments
Time Frame: during the operation
during the operation
number of use for each surgical instruments
Time Frame: during the operation
during the operation

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hyoung-Il Kim, Yonsei University

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)

May 18, 2021

Primary Completion (Anticipated)

May 9, 2022

Study Completion (Anticipated)

July 9, 2022

Study Registration Dates

First Submitted

July 4, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2021-0409

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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