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Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

Primary Purpose

Postoperative Inflammation, Postoperative Fever

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ULTRACISION Harmonic Scalpel
Ligasure Maryland
Thunderbeat
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Inflammation focused on measuring fever, inflammation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • pathologically proven adenocarcinoma in stomach
  • patients who are expected for R0 resection with distal gastrectomy
  • pre-operative clinical stage should be stage I
  • patients who is able to be followed up with in postoperative 30 days
  • patients whose CRP is normal before surgery

Exclusion Criteria:

  • patients who had an abdominal surgery
  • patients who received chemotherapy, radiotherapy before surgery
  • patients who received ESD before surgery
  • Patietns who had an ascites on pre-operative CT scan
  • liver cirrhosis
  • cardiovascular disease (Ejection Fraction<50%)
  • serum creatinine > 1.4 mg/dL or BUN>26mg/dL
  • PT INR >1.2 or aPTT>45sec
  • uncontrolle diabetes
  • Crohn's disease, ulcerative colitis
  • patients who receives anti-coagulants
  • patients who need pre-operative steroid booster because of steroid treatment
  • pregnancy
  • patients who have allergic reaction to iodine

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ULTRACISION Harmonic Scalpel

Ligasure Maryland

Thunderbeat

Arm Description

Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy

Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy

Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy

Outcomes

Primary Outcome Measures

postoperative 2nd day CRP
To check the postoperative 2nd day CRP level in each group

Secondary Outcome Measures

postoperative 4th day CRP
To check the postoperative 4th day CRP level in each group
postoperative IL-6, IL10 level
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

Full Information

First Posted
November 24, 2017
Last Updated
March 23, 2023
Sponsor
Seoul National University Hospital
Collaborators
Medtronic Spine LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03356626
Brief Title
Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy
Official Title
Comparison of Perioperative Outcomes Between Bipolar Sealing Device and Ultrasonic Shears During Laparoscopic Gastrectomy for Early Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
August 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Medtronic Spine LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat comparing postoperative CRP level in each group
Detailed Description
To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat comparing postoperative CRP level in each group post operative 2nd day CRP level post operative 4th day CRP level post operative IL-6, 10 level in 2nd, 4th day

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Inflammation, Postoperative Fever
Keywords
fever, inflammation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ULTRACISION Harmonic Scalpel
Arm Type
Experimental
Arm Description
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy
Arm Title
Ligasure Maryland
Arm Type
Experimental
Arm Description
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy
Arm Title
Thunderbeat
Arm Type
Experimental
Arm Description
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy
Intervention Type
Device
Intervention Name(s)
ULTRACISION Harmonic Scalpel
Intervention Description
to use ULTRACISION Harmonic Scalpel when performing gastrectomy
Intervention Type
Device
Intervention Name(s)
Ligasure Maryland
Intervention Description
to use Ligasure Maryland when performing gastrectomy
Intervention Type
Device
Intervention Name(s)
Thunderbeat
Intervention Description
to use Thunderbeat when performing gastrectomy
Primary Outcome Measure Information:
Title
postoperative 2nd day CRP
Description
To check the postoperative 2nd day CRP level in each group
Time Frame
2nd day
Secondary Outcome Measure Information:
Title
postoperative 4th day CRP
Description
To check the postoperative 4th day CRP level in each group
Time Frame
4th day
Title
postoperative IL-6, IL10 level
Description
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Time Frame
2nd, 4th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pathologically proven adenocarcinoma in stomach patients who are expected for R0 resection with distal gastrectomy pre-operative clinical stage should be stage I patients who is able to be followed up with in postoperative 30 days patients whose CRP is normal before surgery Exclusion Criteria: patients who had an abdominal surgery patients who received chemotherapy, radiotherapy before surgery patients who received ESD before surgery Patietns who had an ascites on pre-operative CT scan liver cirrhosis cardiovascular disease (Ejection Fraction<50%) serum creatinine > 1.4 mg/dL or BUN>26mg/dL PT INR >1.2 or aPTT>45sec uncontrolle diabetes Crohn's disease, ulcerative colitis patients who receives anti-coagulants patients who need pre-operative steroid booster because of steroid treatment pregnancy patients who have allergic reaction to iodine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Ho Kong, MD,PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

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