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

Phase 3

• Conditions: Stomach Cancer; Gastrectomy; Ultrasonic Coagulating Shears
• Interventions: Device: Ultrasonic Coagulating Shears

• Registration Number: NCT01179750
• Lead Sponsor: Samsung Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-14
• Last Update Posted: 2010-12-16
• Primary Completion: 2011-04
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasonic coagulation shears group	Ultrasonic Coagulating Shears	the other arm: operated group using ultrasonic coagulation shears during gastrectomy

Primary Outcome Measures

Name	Time	Method
operation time	2 weeks later after operation	operation time: a time from the opening of peritoneal cavity to the retrieval of specimen
amount of blood loss	2 weeks later after operation	amount of blood loss: an amount of blood loss during operation time

Secondary Outcome Measures

Name	Time	Method
C-reactive protein	post operative day #0, #1, #5
total lymphocyte count	post operative day #0, #1, #5
postoperative complications	4 weeks later after operation
drainage from peritoneal cavity during hospital	2 weeks later after operation	amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of