MedPath

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

Phase 2
Conditions
Gastric cancer
Registration Number
JPRN-UMIN000003300
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
130
Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath