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

An Analysis of Costs and Outcomes Based on the Open, Laparoscopic, and Da Vinci Robotic Approach for Gastric Cancer Resection.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03447106
Acronym
Cooladvrsigcr
Enrollment
500
Registered
2018-02-27
Start date
2018-02-28
Completion date
2020-12-31
Last updated
2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

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.

Interventions

PROCEDURElaparotomy

This is a kind of traditional surgical method.

PROCEDURELaparoscopic

laparoscopic surgery

PROCEDURERobotic

the Da Vinci robot assisted gastric resection

Sponsors

Air Force Military Medical University, China
CollaboratorOTHER
First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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

* 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;

Design outcomes

Primary

MeasureTime frame
Tumor recurrence rate2 years
cost of treatment2 years

Secondary

MeasureTime frame
the operation timeone hour-six hours

Other

MeasureTime frame
the all number of postoperative complications( frequency,reflux esophagitis and bile reflux gastritis)2 years

Countries

China

Contacts

Primary ContactJun Jun She, M.D; PhD
sjuns@sina.com008618991232713

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026