Randomized phase II study of clinical effect of Vessel Sealing System (Ligasure) for open gastrectomy.

UMIN ID: UMIN000003300

Registered date:10/03/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 2009/01/01
• Target sample size: 130
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Open gastrectomy with Vessel Sealing System.
Open gastrectomy without Vessel Sealing System.

Outcome(s)

• Primary Outcome: Operative blood loss
• Secondary Outcome: Operative time, postoperative complications, postoperative hospital stay, medical costs

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: 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.

Related Information

• Primary Sponsor: Multicenter Clinical Study Group of Osaka(MCSGO)
• Source(s) of Monetary Support: none