Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer

Stomach Neoplasms Clinical Trial

— LCFRAGIGC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940417
• Other study ID #: XJTU1AF2019LSK-005
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: November 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Junjun She, MD,PHD
• Phone: 0086-18991232713
• Email: junjunshe1975[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Xi'an Jiao Tong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time,min	The surgeon begins the operation until the incision is closed	1 week
Primary	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	Evaluated blood loss ,ml	The amount of bleeding in the suction device plus the amount of bleeding dipped in the gauze	1 week
Secondary	Number of retrieved lymph nodes	Refer to the postoperative pathology report	1 week
Secondary	Day of ?rst ?atus,day		2 week
Secondary	Day of ?rst ?uid diet,day		2 week
Secondary	the rate of postoperative complications	Postoperative complications included infectious complications, intra-abdominal/intraluminal bleeding, gastric stasis and leakage	30 days after the operation
Secondary	postoperative hospital stay, days	Length of postoperative hospital stay	30 days after the operation
Secondary	cost	total cost in the hospital	30 days after the operation