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Articulated Laparoscopic Instruments Clinical Study

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05550974
Enrollment
1155
Registered
2022-09-22
Start date
2022-09-30
Completion date
2024-12-31
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Articulated laparoscopic instruments, gastrointestinal surgery, complication

Brief 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.

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.

Interventions

DEVICEMinimally Invasive Surgery

gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Patients with gastric cancer shcedulled for gastrectomy

Exclusion criteria

Vulnerable subject (illiterate, pregnant)

Design outcomes

Primary

MeasureTime frameDescription
complication1 month after surgeryOne of the most important surgical outcome, complication will be measured at 1 month after surgery

Secondary

MeasureTime frameDescription
Surgical outcome: bleeding(ml)1 month after surgeryoperative 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 score1 month after surgeryVisual 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: operative time(min)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 instrumentsduring the operationDuration for each surgical instruments
number of use for each surgical instrumentsduring the operationnumber of use for each surgical instruments
Surgical outcome: serum Amylase(U/L)1 month after surgery

Countries

South Korea

Contacts

Primary ContactHyoung-Il Kim
cairus@yuhs.ac02-2228-2095

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026