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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Open

Group Type EXPERIMENTAL

laparotomy

Intervention Type PROCEDURE

This is a kind of traditional surgical method.

Laparoscopic

Group Type EXPERIMENTAL

Laparoscopic

Intervention Type PROCEDURE

laparoscopic surgery

Robotic

Group Type EXPERIMENTAL

Robotic

Intervention Type PROCEDURE

the Da Vinci robot assisted gastric resection

Interventions

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laparotomy

This is a kind of traditional surgical method.

Intervention Type PROCEDURE

Laparoscopic

laparoscopic surgery

Intervention Type PROCEDURE

Robotic

the Da Vinci robot assisted gastric resection

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Eligible Sex

ALL

Accepts Healthy Volunteers

No