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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01179750
Recruitment Status : Unknown
Verified December 2010 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : August 11, 2010
Last Update Posted : December 16, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Stomach Cancer Gastrectomy Ultrasonic Coagulating Shears Device: Ultrasonic Coagulating Shears Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
Study Start Date : January 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. operation time [ Time Frame: 2 weeks later after operation ]
    operation time: a time from the opening of peritoneal cavity to the retrieval of specimen

  2. amount of blood loss [ Time Frame: 2 weeks later after operation ]
    amount of blood loss: an amount of blood loss during operation time

Secondary Outcome Measures :
  1. C-reactive protein [ Time Frame: post operative day #0, #1, #5 ]
  2. total lymphocyte count [ Time Frame: post operative day #0, #1, #5 ]
  3. postoperative complications [ Time Frame: 4 weeks later after operation ]
  4. drainage from peritoneal cavity during hospital [ Time Frame: 2 weeks later after operation ]
    amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01179750

Contact: Jae Moon Bae, Professor +82-2-3410-0252

Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: JaeMoon Bae, MD.,Ph.D.    82-2-3410-0252   
Contact: SeungJong Oh, MD    82-2-3410-1735   
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Jae Moon Bae, MD., Ph.D. Samsung Medical Center, Sungkyunkwan University

Responsible Party: Jae Moon Bae, Samsung Medical Center, Sungkyunkwan University School of Medicine Identifier: NCT01179750     History of Changes
Other Study ID Numbers: 2009-08-089
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: December 16, 2010
Last Verified: December 2010

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
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases