Articulated Laparoscopic Instruments Clinical Study

Yonsei University

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Device: Minimally Invasive Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05550974

4-2022-0414

Details and patient eligibility

About

Recently, with the development of minimally invasive surgery and the development of instruments, laparoscopic and robotic surgery are increasing, and laparoscopic and robotic surgery are evolving. The association between the new surgical instruments used in each upper gastrointestinal surgery and the results has been traditionally analyzed through the learning curve, and in addition, the study aims to collect and analyze the utilization of the instrument and surgical results prospectively through surgical video analysis.

Full description

Prior to surgery, all patients subject to the study are explained and informed of the prior consent form of prior consent is delivered. During surgery, video recording is performed to check the type of surgical instrument, the time of use, and the event that occurred during surgery. After surgery, the morbidity after surgery will be monitored and recorded. Additional morbidity will be recorded one to three months after surgery.

Enrollment: 1,155 estimated patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with gastric cancer shcedulled for gastrectomy

Exclusion criteria

Vulnerable subject (illiterate, pregnant)

Trial design

1,155 participants in 6 patient groups

LC

Description:

laparoscopic surgery using conventional laparoscopic instruments

Treatment:

Device: Minimally Invasive Surgery

LW

Description:

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

Treatment:

Device: Minimally Invasive Surgery

RC

Description:

Conventional robotic surgery

RSS

Description:

Use of singlesite 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