CClinicalTrials.gg
Status unknownNCT03447106CooladvrsigcrUpdated Mar 2, 2018

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

An interventional study of laparotomy and Laparoscopic in Stomach Neoplasms, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-03-02.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Stomach Neoplasms

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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;
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Open

    Procedure: laparotomy

  • Experimental
    Laparoscopic

    Procedure: Laparoscopic

  • Experimental
    Robotic

    Procedure: Robotic

Interventions

  • Procedurelaparotomy

    This is a kind of traditional surgical method.

  • ProcedureLaparoscopic

    laparoscopic surgery

  • ProcedureRobotic

    the Da Vinci robot assisted gastric resection

05

What researchers measure

Primary outcomes

  1. Tumor recurrence rate

    Time frame: 2 years

  2. cost of treatment

    Time frame: 2 years

Secondary outcomes

  1. the operation time

    Time frame: one hour-six hours

Other outcomes

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

    Time frame: 2 years

06

Study locations

1 site
  • First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
    • Jun Jun She, M.D.;Ph.D. · Contact · sjuns@sina.com · 0086-18991232713
07

Registry details

Key details

Study ID
NCT03447106
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Air Force Military Medical University, China
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Feb 28, 2018 (estimated)
Primary completion
Feb 28, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Mar 2, 2018

Study contacts

Jun Jun She, M.D; PhD
Contact
sjuns@sina.com
008618991232713
Jun Jun She, M.D; PhD
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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