Randomized phase II study of clinical effect of ultrasonically activated coagulating shears (Harmonic scalpel) for open gastrectomy.
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000003303
- Lead Sponsor
- Multicenter Clinical Study Group of Osaka (MCSGO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 230
Not provided
1)Cancer of gastric remnant. 2)Intention of laparoscopic gastrectomy. 3)Prescribed antiplatelet and anticoagulant agent which needs alternative administration of heparin in the perioperative period. 4)Non curative factors proven by preoperative examinations. 5)Preoperative chemotherapy. 6)Synchronous malignancies other than carcinoma in situ of cervical cancer or focal cancer in adenoma of colorectal cancer. 7)Metachronous malignancies within 5 years or with tumor recurrence. 8)Severe respiratory dysfunction. 9)History of myocardinal infarction within 6 months before surgery. 10)Liver cirrhosis or active hepatitis. 11)Chronic renal failure with hemodialysis. 12)Uncontrolled diabetes mellitus (HbA1c 9.0 or more). 13)Other unfeasible factors to perform study safely approved by attending surgeon.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Operative time from skin incision to resection of gastric specimen
- Secondary Outcome Measures
Name Time Method total operative time, operative blood loss, postoperative complications, postoperative hospital stay, medical costs.