Comparison of Open Laparoscopic and Robotic Surgery in Gastric Cancer Resection.

Stomach Neoplasms Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03447106
• Other study ID #: XJTU1AF-CRF-2018-001
• Status: Not yet recruiting
• Phase: N/A
• First received: February 21, 2018
• Last updated: February 28, 2018
• Start date: February 28, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jun Jun She, M.D; PhD
• Phone: 008618991232713
• Email: sjuns[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• laparotomy
This is a kind of traditional surgical method.
• Laparoscopic
laparoscopic surgery
• Robotic
the Da Vinci robot assisted gastric resection

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the all number of postoperative complications( frequency,reflux esophagitis and bile reflux gastritis)		2 years
Primary	Tumor recurrence rate		2 years
Primary	cost of treatment		2 years
Secondary	the operation time		one hour-six hours