Clinical trial NCT04972149: Cohort Study Comparing Surgeon Stress, Utilization of Surgical Instruments, Surgical Outcomes According to Surgical Approach for Gastrectomy
Official title: Cohort Study Comparing Surgeon Stress, Utilization of Surgical Instruments, Surgical Outcomes According to Surgical Approach for Gastrectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer Patients Undergoing Gastrectomy
Keywords: surgeon stress
instrument
outcome
complication
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 250
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
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: A new surgical instrument is supposed to allow surgeon to do surgery with better performance. However, the learning period before getting used to the new instruments is necessary. The surgeon's stress to overcome the learning effect and the surgical outcome was rarely assessed. The comparative analysis of surgical outcome, surgeon's stress, and utilization of instruments for gastrectomy will be performed in prospective cohort study

Detailed description: Before the surgery, all the eligible patients will be explained regarding the study and informed consent will be given. During the surgery, the surgeon will wear heart rate monitoring device to monitor hear rate variability of the surgeon. The surgical procedure will be recorded. After the surgery, morbidity following surgery will be monitored and recorded. At 1 month after surgery, additional morbidity will be recorded.

Eligibility criteria: Inclusion Criteria:

Patients with gastric cancer scheduled for gastrectomy

Exclusion Criteria:

Vulnerable subject (illiterate, pregnant)

Primary outcomes:
measure: complication
timeFrame: 1 month after surgery
Secondary outcomes:
measure: operative time (min)
timeFrame: 1 month after surgery
measure: bleeding(ml)
timeFrame: 1 month after surgery
measure: gas passing(day)
timeFrame: 1 month after surgery
measure: hospital stay(day)
timeFrame: 1 month after surgery
measure: readmission rate(percent)
timeFrame: 1 month after surgery
measure: Heart rate variability of surgeon
timeFrame: during the operation
measure: Duration 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: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Yonsei University
name: Hyoung-Il Kim
role: PRINCIPAL_INVESTIGATOR
References:
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