Randomized controlled phase II trial to evaluate non-inferiority of using linear stapling device with bioabsorbable polyglycolic acid sheet to reinforcement with buried suture for duodenal stump in robotic gastric cancer surgery
Not Applicable
Recruiting
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000051052
- Lead Sponsor
- Iwate Prefectural Isawa Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
1)Synchronous or metachronous (within 5 years) malignancies. 2)Infectious disease requiring systemic treatment. 3)Body temperature of 38 degrees Celsius or higher. 4)During pregnancy, within 28 days postpartum, or during lactation. 5)Severe mental disease. 6)Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7)History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 8)Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy. 9)HIV antibody positive. 10)Uncontrolled diabetes mellitus. 11)Respiratory disease requiring continuous oxygen administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of duodenal stump leakage after gastrectomy
- Secondary Outcome Measures
Name Time Method 1. operative time, 2. estimated blood loss, 3. incidence of postoperative complication, 4. hemostasis at duodenal stump, 5. injury at duodenal stump, 6. postoperative hospital stay