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Clinical Trials/NCT03447106
NCT03447106UnknownNot Applicable

An Analysis of Costs and Outcomes Based on the Open, Laparoscopic, and Da Vinci Robotic Approach for Gastric Cancer Resection.

First Affiliated Hospital Xi'an Jiaotong University1 site in 1 country500 target enrollmentStarted: February 28, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
500
Locations
1
Primary Endpoint
Tumor recurrence rate

Study Overview

Brief Summary

Gastric cancer is a common gastrointestinal tumor, and surgical operation is still the main method of gastric cancer treatment. Reported for the first time since 1994, the laparoscopic gastric cancer radical prostatectomy, laparoscopic technique is widely applied in the field of gastrointestinal surgery, has gradually replaced the traditional open operation as the main mode of surgical treatment for gastric cancer. Although laparoscopy has many advantages, there are still disadvantages, such as the discomfort of the physician, the reverse operation, and the ease of shaking, which hinder the application of laparoscopy. In recent years, the Da Vinci robot assisted gastric resection has become a new way to treat gastric cancer. Compared with the traditional laparoscopy and laparotomy, the operation of the robot is more precise and flexible, with obvious advantages of minimally invasive and good application value and prospect. The aim of the study is to compare value (outcomes/costs) of surgery in patients with Gastric Cancer by 3 approaches: open, laparoscopic, and robotic.First of all, the investigators will collect 500 cases of Gastric Cancer patients, randomly assigned for the open, laparoscopic, and robotic group. Secondly, to analyzing the demographic data,basic treatment and follow-up data, including the operation time, blood loss, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients without contraindications gastroscope,surgery and anesthesia;
  • There is no history of abdominal surgery, no severe abdominal cavity adhesion
  • Patients signed informed consent

Exclusion Criteria

  • Patients with preoperative assessment of distant metastasis;
  • Patients with preoperative radiation and chemotherapy or hormone therapy;
  • Patients with acute obstruction, bleeding or perforation of the emergency surgery
  • Patients with a history of abdominal trauma or abdominal surgery.
  • Patients with contraindications gastroscope,surgery and anesthesia;

Arms & Interventions

Open

Experimental

Intervention: laparotomy (Procedure)

Laparoscopic

Experimental

Intervention: Laparoscopic (Procedure)

Robotic

Experimental

Intervention: Robotic (Procedure)

Outcomes

Primary Outcomes

Tumor recurrence rate

Time Frame: 2 years

cost of treatment

Time Frame: 2 years

Secondary Outcomes

  • the operation time(one hour-six hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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