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

Primary Purpose

Stomach Cancer, Gastrectomy, Ultrasonic Coagulating Shears

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasonic Coagulating Shears
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Cancer focused on measuring Ultrasonic coagulating shears in gastrectomy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Ultrasonic Coagulating Shears group

ultrasonic coagulation shears group

Arm Description

the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy;

the other arm: operated group using ultrasonic coagulation shears during gastrectomy

Outcomes

Primary Outcome Measures

operation time
operation time: a time from the opening of peritoneal cavity to the retrieval of specimen
amount of blood loss
amount of blood loss: an amount of blood loss during operation time

Secondary Outcome Measures

C-reactive protein
total lymphocyte count
postoperative complications
drainage from peritoneal cavity during hospital
amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital

Full Information

First Posted
July 27, 2010
Last Updated
December 14, 2010
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01179750
Brief Title
The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
Official Title
The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Cancer, Gastrectomy, Ultrasonic Coagulating Shears
Keywords
Ultrasonic coagulating shears in gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Ultrasonic Coagulating Shears group
Arm Type
No Intervention
Arm Description
the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy;
Arm Title
ultrasonic coagulation shears group
Arm Type
Experimental
Arm Description
the other arm: operated group using ultrasonic coagulation shears during gastrectomy
Intervention Type
Device
Intervention Name(s)
Ultrasonic Coagulating Shears
Other Intervention Name(s)
Harmonic Ace
Intervention Description
comparison of operated groups between with Ultrasonic Coagulating Shears and without them.
Primary Outcome Measure Information:
Title
operation time
Description
operation time: a time from the opening of peritoneal cavity to the retrieval of specimen
Time Frame
2 weeks later after operation
Title
amount of blood loss
Description
amount of blood loss: an amount of blood loss during operation time
Time Frame
2 weeks later after operation
Secondary Outcome Measure Information:
Title
C-reactive protein
Time Frame
post operative day #0, #1, #5
Title
total lymphocyte count
Time Frame
post operative day #0, #1, #5
Title
postoperative complications
Time Frame
4 weeks later after operation
Title
drainage from peritoneal cavity during hospital
Description
amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital
Time Frame
2 weeks later after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Moon Bae, Professor
Phone
+82-2-3410-0252
Email
jmoon.bae@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Moon Bae, MD., Ph.D.
Organizational Affiliation
Samsung Medical Center, Sungkyunkwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JaeMoon Bae, MD.,Ph.D.
Phone
82-2-3410-0252
Email
jmoon.bae@samsung.com
First Name & Middle Initial & Last Name & Degree
SeungJong Oh, MD
Phone
82-2-3410-1735
Email
seungjong.oh@samsung.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
11865342
Citation
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. doi: 10.1007/s00268-001-0199-9. Epub 2001 Dec 4.
Results Reference
background

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

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