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Clinical Trials/NCT05550974
NCT05550974
Recruiting
Not Applicable

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

Yonsei University1 site in 1 country1,155 target enrollmentSeptember 2022
ConditionsGastric Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Yonsei University
Enrollment
1155
Locations
1
Primary Endpoint
complication
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2022
End Date
December 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with gastric cancer shcedulled for gastrectomy

Exclusion Criteria

  • Vulnerable subject (illiterate, pregnant)

Outcomes

Primary Outcomes

complication

Time Frame: 1 month after surgery

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

Secondary Outcomes

  • Surgical outcome: pain score(1 month after surgery)
  • Surgical outcome: serum CRP(mg/L)(1 month after surgery)
  • Surgical outcome: bleeding(ml)(1 month after surgery)
  • Surgical outcome: serum Lipase(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)
  • Surgical outcome: Drain Amylase(U/L)(1 month after surgery)
  • Surgical outcome: hospital stay(day)(1 month after surgery)
  • Surgical outcome: readmission rate(%)(1 month after surgery)
  • Surgical outcome: serum Amylase(U/L)(1 month after surgery)
  • Surgical outcome: operative time(min)(1 month after surgery)
  • number of use for each surgical instruments(during the operation)

Study Sites (1)

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