NCT03447106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

February 28, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 21, 2018

Last Update Submit

February 28, 2018

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Tumor recurrence rate

    2 years

  • cost of treatment

    2 years

Secondary Outcomes (1)

  • the operation time

    one hour-six hours

Other Outcomes (1)

  • the all number of postoperative complications（ frequency,reflux esophagitis and bile reflux gastritis）

    2 years

Study Arms (3)

Open

EXPERIMENTAL
Procedure: laparotomy

Laparoscopic

EXPERIMENTAL
Procedure: Laparoscopic

Robotic

EXPERIMENTAL
Procedure: Robotic

Interventions

laparotomyPROCEDURE

This is a kind of traditional surgical method.

Open
LaparoscopicPROCEDURE

laparoscopic surgery

Laparoscopic
RoboticPROCEDURE

the Da Vinci robot assisted gastric resection

Robotic

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

LaparotomyLaparoscopyRobotics

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresAutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Jun Jun She, M.D; PhD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Jun She, M.D; PhD

CONTACT

008618991232713sjuns@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2018

First Posted

February 27, 2018

Study Start

February 28, 2018

Primary Completion

February 28, 2020

Study Completion

December 31, 2020

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

CN(1)