Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer (LCFRAGIGC)

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

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 Overview

• Status: Unknown
• Conditions: Stomach Neoplasms

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Junjun She, MD,PHD; Phone Number: 0086-18991232713; Email: junjunshe1975@sina.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiao Tong University
      • Contact: Bingyin Shi, MD,PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients were scheduled to undergo minimally invasive gastric cancer surgery and meet the above conditions

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluated blood loss ,ml	The amount of bleeding in the suction device plus the amount of bleeding dipped in the gauze	1 week
Number of retrieved lymph nodes	Refer to the postoperative pathology report	1 week
Day of first flatus,day		2 week
Day of first fluid diet,day		2 week
the rate of postoperative complications	Postoperative complications included infectious complications, intra-abdominal/intraluminal bleeding, gastric stasis and leakage	30 days after the operation
postoperative hospital stay, days	Length of postoperative hospital stay	30 days after the operation
cost	total cost in the hospital	30 days after the operation

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): February 28, 2020

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: May 4, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 4, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: XJTU1AF2019LSK-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No