Clinical trial NCT05550974: Articulated Laparoscopic Instruments Clinical Study
Official title: Articulating Laparoscopic Instrument Assisted Minimally Invasive Upper GastroIntestinal Surgery: AMUGIS Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: Articulated laparoscopic instruments
gastrointestinal surgery
complication
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 1155
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastric cancer scheduled to undergo gastrectomy in high volume center

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.

Eligibility criteria: Inclusion Criteria:

Patients with gastric cancer shcedulled for gastrectomy

Exclusion Criteria:

Vulnerable subject (illiterate, pregnant)

Primary outcomes:
measure: complication
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Surgical outcome: operative time(min)
timeFrame: 1 month after surgery
measure: Surgical outcome: bleeding(ml)
timeFrame: 1 month after surgery
measure: Surgical outcome: pain score
timeFrame: 1 month after surgery
measure: Surgical outcome: hospital stay(day)
timeFrame: 1 month after surgery
measure: Surgical outcome: readmission rate(%)
timeFrame: 1 month after surgery
measure: Surgical outcome: serum CRP(mg/L)
timeFrame: 1 month after surgery
measure: Surgical outcome: serum Amylase(U/L)
timeFrame: 1 month after surgery
measure: Surgical outcome: serum Lipase(U/L)
timeFrame: 1 month after surgery
measure: Surgical outcome: Drain Amylase(U/L)
timeFrame: 1 month after surgery
measure: Surgical outcome: Drain Lipase(U/L)
timeFrame: 1 month after surgery
measure: Duration of use for each surgical instruments
timeFrame: during the operation
measure: number of use for each surgical instruments
timeFrame: during the operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Yonsei University Health System, Severance Hospital
name: Hyoung-Il Kim
role: PRINCIPAL_INVESTIGATOR
References: