Randomized controlled trial to evaluate the effects of the surgical instrument LigaSure on reduction of time of liver transection time, compared with the conventional clamp crushing method at the single institution

UMIN ID: C000000337

Registered date:24/02/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients undergoing liver resection.
• Date of first enrollment: 2006/02/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Liver transcetion using LigaSure
Liver transection by the clamp crushing method

Outcome(s)

• Primary Outcome: Liver transection time in hepatectomy
• Secondary Outcome: Transection area per minute, total operation time, total amount of bleeding, amount of bleeding during transection, amount of transfusion, incidence of bile leakage, postoperative bleeding, incidence of pleural effusion/ascites, hospital stay, postoperative iver function, total bilirubin value of the drained discharge

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1.Simultaneous development of other malignant disease (except a colorectal carcinoma associated with liver metastasis) 2.Cases with high-risks of bleeding, for example; platele counts < 50000/mm3, bleeding time > 5min., PT% < 50% 3.Cases in which inflow occulusion is impossible. 4.Cases with bilio-enteric reconstruction 5.Emergency operation case 6.Cases with some complications of heart, lung, and kidney.

Related Information

• Primary Sponsor: Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Tokyo University Hospital
• Source(s) of Monetary Support: None