Articulated Laparoscopic Instruments Clinical Study

Articulating Laparoscopic Instrument Assisted Minimally Invasive Upper GastroIntestinal Surgery: AMUGIS Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Device: Minimally Invasive Surgery

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1155

Contacts and Locations

• Study Contact: Name: Hyoung-Il Kim; Phone Number: 02-2228-2095; Email: cairus@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health system, Severance Hospital
    • Contact: Hyoung-Il Kim; Phone Number: 02-2228-2095; Email: cairus@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (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 shcedulled for gastrectomy

Exclusion Criteria:

Vulnerable subject (illiterate, pregnant)

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LC; laparoscopic surgery using conventional laparoscopic instruments	Device: Minimally Invasive Surgery; gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures; Other Names: Laparoscopic Surgery
RC; Conventional 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
LW; Using wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated gasper)	Device: Minimally Invasive Surgery; gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures; Other Names: Laparoscopic Surgery
RSS; Use of singlesite system for reduced port robotic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication	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	Measure Description	Time Frame
Surgical outcome: operative time(min)		1 month after surgery
Surgical outcome: bleeding(ml)	operative time(min), bleeding(ml), pain score, hospital stay(day), readmission rate(%), serum CRP(mg/L), serum Amylase(U/L), serum Lipase(U/L), Drain Amylase(U/L), Drain Lipase(U/L)	1 month after surgery
Surgical outcome: pain score	Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	1 month after surgery
Surgical outcome: hospital stay(day)		1 month after surgery
Surgical outcome: readmission rate(%)		1 month after surgery
Surgical outcome: serum CRP(mg/L)		1 month after surgery
Surgical outcome: serum Amylase(U/L)		1 month after surgery
Surgical outcome: serum Lipase(U/L)		1 month after surgery
Surgical outcome: Drain Amylase(U/L)		1 month after surgery
Surgical outcome: Drain Lipase(U/L)		1 month after surgery
Duration of use for each surgical instruments	Duration for each surgical instruments	during the operation
number of use for each surgical instruments	number of use for each surgical instruments	during the operation

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Hyoung-Il Kim, Yonsei University Health system, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: complication; gastrointestinal surgery; Articulated laparoscopic instruments
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 4-2022-0414

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: Yes