Cumulative Summation Analysis of Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Operation time,min
Study Overview
Brief Summary
The investigators prospectively collected the clinical data of Da Vinci robot-assisted radical gastrectomy patients conducted by the same group of physicians from October 2017 to October 2018. The learning curve of the surgery was analyzed with the moving average method and the cumulative sum analysis (CUSUM). The short-term efficacy was then validated by comparing the perioperative and pathologic outcomes of patients in the two stages of the learning curve.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1.Patients were 18-90 years old
- •Patients with a documented diagnosis of gastric adenocarcinoma
- •patients were scheduled to undergo minimally invasive gastric cancer surgery
- •4.patients with no preoperative evidence of serosal invasion or extraperigastric lymph node metastasis on preoperative computed tomography scans, upper endoscopy, and endoscopic ultrasound
Exclusion Criteria
- •Patients with neoadjuvant treatment
- •Patients procedure concurrent with the gastrectomy
- •3.Patients with palliative surgery
- •Patients with the contraindications for general anesthesia
- •Patients were pregnant or mentally incompetent
- •Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension
Outcomes
Primary Outcomes
Operation time,min
Time Frame: 1 week
The surgeon begins the operation until the incision is closed
Docking time,min
Time Frame: 1 week
From the skin cutting through the observation hole to the robot moving to the designated position, the lens and the instrument arm enter the abdominal cavity and prepare for this period
Secondary Outcomes
- Number of retrieved lymph nodes(1 week)
- Day of first flatus,day(2 week)
- Day of first fluid diet,day(2 week)
- the rate of postoperative complications(30 days after the operation)
- postoperative hospital stay, days(30 days after the operation)
- cost(30 days after the operation)
- Evaluated blood loss ,ml(1 week)