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A phase II study to evaluate the safety of first-time radical gastrectomy by robotic approach for stomach cancer in an early stage

Not Applicable
Recruiting
Conditions
Gastric cancer
Registration Number
JPRN-UMIN000053317
Lead Sponsor
Iwate Prefectural Isawa Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
22
Inclusion Criteria

Not provided

Exclusion Criteria

1)Synchronous or metachronous (within 5 years) malignancies. 2)During pregnancy, within 28 days postpartum, or during lactation. 3)Severe mental disease. 4)Receiving continuous systemic corticosteroid or immunosuppressant treatment. 5)History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 6)Poorly controlled hypertension. 7)Uncontrolled diabetes mellitus. 8)Respiratory disease requiring continuous oxygen administration.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of intra-abdominal infectious complications after gastrectomy
Secondary Outcome Measures
NameTimeMethod
1. overall survival, 2. relapse-free survival, 3. completion rate of robotic surgeries, 4. incidence of adverse events
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