Articulated Laparoscopic Instruments Clinical Study

NCT05550974 — Unknown, 1155 participants, Yonsei University

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

Registry	NCT05550974
Status	Unknown
Study type	Observational
Enrollment	1155 (Estimated)
Sponsor	Yonsei University (Other)
Conditions	Gastric Cancer
Interventions	Minimally Invasive Surgery (Device)
Dates	start 2022-09-01 (estimated), primary completion 2024-10-01 (estimated), completion 2024-12-01 (estimated), first posted 2022-09-22, last updated 2022-10-03
Locations	1 site in South Korea

-Summary

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.

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+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.

+Arms and interventions

Arm	Interventions	Description
LC	Device: Minimally Invasive Surgery	laparoscopic surgery using conventional laparoscopic instruments
LW	Device: Minimally Invasive Surgery	Using wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated gasper)
RC		Conventional robotic surgery
RSS		Use of singlesite system for reduced port 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

Minimally Invasive Surgery (Device), also known as Laparoscopic Surgery: gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures

+Outcome measures

Primary outcomes

complication [1 month after surgery]: One of the most important surgical outcome, complication will be measured at 1 month after surgery

Secondary outcomes

Surgical outcome: operative time(min) [1 month after surgery]
Surgical outcome: bleeding(ml) [1 month after surgery]: 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)
Surgical outcome: pain score [1 month after surgery]: 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').
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 [during the operation]: Duration for each surgical instruments
number of use for each surgical instruments [during the operation]: number of use for each surgical instruments

+Eligibility

Sex: All, ages: 19 Years to 90 Years

Inclusion Criteria:

Patients with gastric cancer shcedulled for gastrectomy

Exclusion Criteria:

Vulnerable subject (illiterate, pregnant)

+Locations (1)

Facility	City	Country	Status
Yonsei University Health System, Severance Hospital	Seoul	South Korea	Recruiting

+Investigators

Hyoung-Il Kim, Principal investigator, Yonsei University Health System, Severance Hospital