Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer
LCFRAGIGC
Cumulative Summation Analysis of Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 18, 2018
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedMay 7, 2019
November 1, 2018
2.2 years
November 18, 2018
May 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Operation time,min
The surgeon begins the operation until the incision is closed
1 week
Docking time,min
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
1 week
Secondary Outcomes (7)
Evaluated blood loss ,ml
1 week
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
- +2 more secondary outcomes
Eligibility Criteria
patients were scheduled to undergo minimally invasive gastric cancer surgery and meet the above conditions
You may qualify if:
- Patients were 18-90 years old
- \. Patients with a documented diagnosis of gastric adenocarcinoma
- \. patients were scheduled to undergo minimally invasive gastric cancer surgery
- patients with no preoperative evidence of serosal invasion or extraperigastric lymph node metastasis on preoperative computed tomography scans, upper endoscopy, and endoscopic ultrasound
You may not qualify if:
- \. Patients with neoadjuvant treatment
- \. Patients procedure concurrent with the gastrectomy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710061, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2018
First Posted
May 7, 2019
Study Start
October 1, 2017
Primary Completion
December 31, 2019
Study Completion
February 28, 2020
Last Updated
May 7, 2019
Record last verified: 2018-11