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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01179750
First received: July 27, 2010
Last updated: December 14, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Stomach Cancer
Gastrectomy
Ultrasonic Coagulating Shears
 Device: Ultrasonic Coagulating Shears
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • operation time [ Time Frame: 2 weeks later after operation ] [ Designated as safety issue: No ]
    operation time: a time from the opening of peritoneal cavity to the retrieval of specimen

  • amount of blood loss [ Time Frame: 2 weeks later after operation ] [ Designated as safety issue: No ]
    amount of blood loss: an amount of blood loss during operation time


Secondary Outcome Measures:
  • C-reactive protein [ Time Frame: post operative day #0, #1, #5 ] [ Designated as safety issue: No ]
  • total lymphocyte count [ Time Frame: post operative day #0, #1, #5 ] [ Designated as safety issue: No ]
  • postoperative complications [ Time Frame: 4 weeks later after operation ] [ Designated as safety issue: Yes ]
  • drainage from peritoneal cavity during hospital [ Time Frame: 2 weeks later after operation ] [ Designated as safety issue: No ]
    amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital


Estimated Enrollment: 256
Study Start Date: January 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Ultrasonic Coagulating Shears group
the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy;
Experimental: ultrasonic coagulation shears group
the other arm: operated group using ultrasonic coagulation shears during gastrectomy
 Device: Ultrasonic Coagulating Shears
comparison of operated groups between with Ultrasonic Coagulating Shears and without them.
Other Name: Harmonic Ace

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179750

Contacts
Contact: Jae Moon Bae, Professor +82-2-3410-0252 jmoon.bae@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: JaeMoon Bae, MD.,Ph.D.     82-2-3410-0252     jmoon.bae@samsung.com    
Contact: SeungJong Oh, MD     82-2-3410-1735     seungjong.oh@samsung.com    
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Jae Moon Bae, MD., Ph.D. Samsung Medical Center, Sungkyunkwan University
  More Information

Publications:

Responsible Party: Jae Moon Bae, Samsung Medical Center, Sungkyunkwan University School of Medicine
ClinicalTrials.gov Identifier: NCT01179750     History of Changes
Other Study ID Numbers: 2009-08-089
Study First Received: July 27, 2010
Last Updated: December 14, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Ultrasonic coagulating shears in gastrectomy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 23, 2013