Articulated Laparoscopic Instruments Clinical Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Device: Minimally Invasive Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with gastric cancer shcedulled for gastrectomy Exclusion Criteria: Vulnerable subject (illiterate, pregnant)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LC<br>laparoscopic surgery using conventional laparoscopic instruments | Device: Minimally Invasive Surgery<br>* gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures<br>* Other names: Laparoscopic Surgery;|
| LW<br>Using wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated gasper) | Device: Minimally Invasive Surgery<br>* gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures<br>* Other names: Laparoscopic Surgery;|
| RC<br>Conventional robotic surgery | |
| RSS<br>Use of singlesite system for reduced port robotic surgery | |
| RSP<br>Use of da Vinci SP system for reduced port robotic surgery | |
| RRI<br>A new surgical robot Revo-i developed by Meerae company in Korea | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Articulated laparoscopic instruments, gastrointestinal surgery, complication