The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
Conditions
Stomach Cancer - Gastrectomy - Ultrasonic Coagulating Shears
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Ultrasonic coagulating shears in gastrectomy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Ultrasonic Coagulating Shears
Type: Device
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: JaeMoon Bae, MD.,Ph.D. - 82-2-3410-0252 - jmoon.bae@samsung.com
Start Date
January 2010
Completion Date
June 2011
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page