Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer

• Conditions: Stomach Neoplasms

• Registration Number: NCT03940417
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-18
• Study First Submitted QC: 2019-05-04
• Last Update Submitted: 2019-05-04
• Study First Posted: 2019-05-07
• Last Update Posted: 2019-05-07
• Primary Completion: 2019-12-31
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Operation time,min	1 week	The surgeon begins the operation until the incision is closed
Docking time,min	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 Outcome Measures

Name	Time	Method
Number of retrieved lymph nodes	1 week	Refer to the postoperative pathology report
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 complications included infectious complications, intra-abdominal/intraluminal bleeding, gastric stasis and leakage
postoperative hospital stay, days	30 days after the operation	Length of postoperative hospital stay
cost	30 days after the operation	total cost in the hospital
Evaluated blood loss ,ml	1 week	The amount of bleeding in the suction device plus the amount of bleeding dipped in the gauze

Trial Locations

Locations (1)

the First Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xi'an, Shaanxi, China