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

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ClinicalTrials.gov Identifier: NCT03447106
Recruitment Status : Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
Fourth Military Medical University
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Procedure: laparotomy Procedure: Laparoscopic Procedure: Robotic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Analysis of Costs and Outcomes Based on the Open, Laparoscopic, and Da Vinci Robotic Approach for Gastric Cancer Resection.
Estimated Study Start Date : February 28, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Open Procedure: laparotomy
This is a kind of traditional surgical method.

Experimental: Laparoscopic Procedure: Laparoscopic
laparoscopic surgery

Experimental: Robotic Procedure: Robotic
the Da Vinci robot assisted gastric resection




Primary Outcome Measures :
  1. Tumor recurrence rate [ Time Frame: 2 years ]
  2. cost of treatment [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. the operation time [ Time Frame: one hour-six hours ]

Other Outcome Measures:
  1. the all number of postoperative complications( frequency,reflux esophagitis and bile reflux gastritis) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447106


Contacts
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Contact: Jun Jun She, M.D; PhD 008618991232713 sjuns@sina.com

Locations
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China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting
Xi'an, Shaanxi, China, 710061
Contact: Jun Jun She, M.D.;Ph.D.    0086-18991232713    sjuns@sina.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Fourth Military Medical University
Investigators
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Principal Investigator: Jun Jun She, M.D; PhD First Affiliated Hospital Xi'an Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03447106     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2018-001
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases