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

Stomach Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01179750
• Other study ID #: 2009-08-089
• Status: Unknown status
• Phase: Phase 3
• First received: July 27, 2010
• Last updated: December 14, 2010
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2010
• Source: Samsung Medical Center
• Contact: Jae Moon Bae, Professor
• Phone: +82-2-3410-0252
• Email: jmoon.bae[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 256
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrectomy
• Stomach Cancer
• Stomach Neoplasms
• Ultrasonic Coagulating Shears

Intervention

Device:
• Ultrasonic Coagulating Shears
comparison of operated groups between with Ultrasonic Coagulating Shears and without them.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Tsimoyiannis EC, Jabarin M, Tsimoyiannis JC, Betzios JP, Tsilikatis C, Glantzounis G. Ultrasonically activated shears in extended lymphadenectomy for gastric cancer. World J Surg. 2002 Feb;26(2):158-61. Epub 2001 Dec 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time	operation time: a time from the opening of peritoneal cavity to the retrieval of specimen	2 weeks later after operation
Primary	amount of blood loss	amount of blood loss: an amount of blood loss during operation time	2 weeks later after operation
Secondary	C-reactive protein		post operative day #0, #1, #5
Secondary	total lymphocyte count		post operative day #0, #1, #5
Secondary	postoperative complications		4 weeks later after operation
Secondary	drainage from peritoneal cavity during hospital	amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital	2 weeks later after operation