Comparison of Open Laparoscopic and Robotic Surgery in Gastric Cancer Resection. (Cooladvrsigcr)
Primary Purpose
Stomach Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparotomy
Laparoscopic
Robotic
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms
Eligibility Criteria
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;
Sites / Locations
- First Affiliated Hospital of Xi'an Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Open
Laparoscopic
Robotic
Arm Description
Outcomes
Primary Outcome Measures
Tumor recurrence rate
cost of treatment
Secondary Outcome Measures
the operation time
Full Information
NCT ID
NCT03447106
First Posted
February 21, 2018
Last Updated
February 28, 2018
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT03447106
Brief Title
Comparison of Open Laparoscopic and Robotic Surgery in Gastric Cancer Resection.
Acronym
Cooladvrsigcr
Official Title
An Analysis of Costs and Outcomes Based on the Open, Laparoscopic, and Da Vinci Robotic Approach for Gastric Cancer Resection.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2018 (Anticipated)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Air Force Military Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open
Arm Type
Experimental
Arm Title
Laparoscopic
Arm Type
Experimental
Arm Title
Robotic
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
laparotomy
Intervention Description
This is a kind of traditional surgical method.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic
Intervention Description
laparoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
Robotic
Intervention Description
the Da Vinci robot assisted gastric resection
Primary Outcome Measure Information:
Title
Tumor recurrence rate
Time Frame
2 years
Title
cost of treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
the operation time
Time Frame
one hour-six hours
Other Pre-specified Outcome Measures:
Title
the all number of postoperative complications( frequency,reflux esophagitis and bile reflux gastritis)
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Jun She, M.D; PhD
Phone
008618991232713
Email
sjuns@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Jun She, M.D; PhD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Jun She, M.D.;Ph.D.
Phone
0086-18991232713
Email
sjuns@sina.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Open Laparoscopic and Robotic Surgery in Gastric Cancer Resection.
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