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

• Conditions: Gastric Cancer Patients Undergoing Gastrectomy

• Registration Number: NCT04972149
• Lead Sponsor: Yonsei University

Brief Summary

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

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 Timeline

• Study Start: 2021-05-18
• Status Verified: 2021-07
• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-22
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-26
• Primary Completion: 2022-05-09
• Study Completion: 2022-07-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Patients with gastric cancer scheduled for gastrectomy

Exclusion Criteria

Vulnerable subject (illiterate, pregnant)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complication	1 month after surgery	One of the most important surgical outcome, complication will be measured at 1 month after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of