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

Yonsei University

Status: Unknown

Conditions: Gastric Cancer Patients Undergoing Gastrectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04972149

4-2021-0409

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: Under 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with gastric cancer scheduled for gastrectomy

Exclusion criteria

Vulnerable subject (illiterate, pregnant)

Trial design

250 participants in 6 patient groups

LC

Description:

laparoscopic surgery using conventional laparoscopic instruments

LW

Description:

Using wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated grasper)

RC

Description:

Conventional robotic surgery

RSS

Description:

Use of single site system for reduced port robotic surgery

RSP

Description:

Use of da Vinci SP system for reduced port robotic surgery

RRI

Description:

A new surgical robot Revo-i developed by Meerae company in Korea