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

December 14, 2010 updated by: Samsung Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • Harmonic Ace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks later after operation
amount of blood loss
Time Frame: 2 weeks later after operation
amount of blood loss: an amount of blood loss during operation time
2 weeks later after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein
Time Frame: post operative day #0, #1, #5
post operative day #0, #1, #5
total lymphocyte count
Time Frame: post operative day #0, #1, #5
post operative day #0, #1, #5
postoperative complications
Time Frame: 4 weeks later after operation
4 weeks later after operation
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
2 weeks later after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jae Moon Bae, MD., Ph.D., Samsung Medical Center, Sungkyunkwan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2011

Study Completion (ANTICIPATED)

June 1, 2011

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (ESTIMATE)

August 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2010

Last Update Submitted That Met QC Criteria

December 14, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-08-089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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