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Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer

Cumulative Summation Analysis of Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03940417
Acronym
LCFRAGIGC
Enrollment
100
Registered
2019-05-07
Start date
2017-10-01
Completion date
2020-02-28
Last updated
2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

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.

Interventions

None listed

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 1.Patients were 18-90 years old * 2\. Patients with a documented diagnosis of gastric adenocarcinoma * 3\. 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

* 1\. Patients with neoadjuvant treatment * 2\. Patients procedure concurrent with the gastrectomy * 3.Patients with palliative surgery * 4\. Patients with the contraindications for general anesthesia * 5\. Patients were pregnant or mentally incompetent * 6\. Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension

Design outcomes

Primary

MeasureTime frameDescription
Operation time,min1 weekThe surgeon begins the operation until the incision is closed
Docking time,min1 weekFrom 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

MeasureTime frameDescription
Day of first flatus,day2 week
Day of first fluid diet,day2 week
Evaluated blood loss ,ml1 weekThe amount of bleeding in the suction device plus the amount of bleeding dipped in the gauze
postoperative hospital stay, days30 days after the operationLength of postoperative hospital stay
cost30 days after the operationtotal cost in the hospital
the rate of postoperative complications30 days after the operationPostoperative complications included infectious complications, intra-abdominal/intraluminal bleeding, gastric stasis and leakage
Number of retrieved lymph nodes1 weekRefer to the postoperative pathology report

Countries

China

Contacts

Primary ContactJunjun She, MD,PHD
junjunshe1975@sina.com0086-18991232713

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026