The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Ultrasonic Coagulating Shears; Gastrectomy; Stomach Cancer

Treatments: Device: Ultrasonic Coagulating Shears

Study type: Interventional

Funder types: Other

Identifiers

NCT01179750

2009-08-089

Details and patient eligibility

About

Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once during operation. It was proved that a laparoscopic gastric resection showed significantly shorter operative time and less work load distribution, and more stability of bleeding than before an introduction of ultrasonic coagulating shears .

In an open gastric cancer surgery, ultrasonic coagulating shears have been often used for lymph node dissection or cutting of small vessels in some hospitals in Korea. However its usefulness or effectiveness has not been fully proved. There was only one report about using ultrasonic coagulating shears in open gastrectomy. The report contained small number of subjects and surgical procedures were different from the investigators.

The investigators expect to reduce operative time and blood loss with ultrasonic coagulating shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and shorten the removal time of a drain, which will also shorten the hospital stay.

The objective of this study is to evaluate the safety and benefit of ultrasonic coagulating shears in open gastrectomy including usefulness and effectiveness by a randomized controlled, prospective study.

Enrollment: 256 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with the diagnosis of gastric cancer
• The patient who agrees to participate in this study by signing the informed consent form

Exclusion criteria

• The patient who refuse to participate in this study
• Have simultaneously other cancer
• Underwent cancer therapy at past time
• Have bleeding disorder, coagulation disorder, chronic disease (e.g.heart failure, cardiovascular disease, active hepatitis)
• Have a previous upper gastrointestinal surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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256 participants in 2 patient groups

No Ultrasonic Coagulating Shears group

No Intervention group

Description:

the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy;

ultrasonic coagulation shears group

Experimental group

Description:

the other arm: operated group using ultrasonic coagulation shears during gastrectomy

Treatment:

Device: Ultrasonic Coagulating Shears