Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

March 23, 2023 updated by: Seoul National University Hospital

Comparison of Perioperative Outcomes Between Bipolar Sealing Device and Ultrasonic Shears During Laparoscopic Gastrectomy for Early Gastric Cancer

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

Study Overview

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

  1. post operative 2nd day CRP level
  2. post operative 4th day CRP level
  3. post operative IL-6, 10 level in 2nd, 4th day

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ULTRACISION Harmonic Scalpel
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy
to use ULTRACISION Harmonic Scalpel when performing gastrectomy
Experimental: Ligasure Maryland
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy
to use Ligasure Maryland when performing gastrectomy
Experimental: Thunderbeat
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy
to use Thunderbeat when performing gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative 2nd day CRP
Time Frame: 2nd day
To check the postoperative 2nd day CRP level in each group
2nd day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative 4th day CRP
Time Frame: 4th day
To check the postoperative 4th day CRP level in each group
4th day
postoperative IL-6, IL10 level
Time Frame: 2nd, 4th day
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
2nd, 4th day

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Seong-Ho Kong, MD,PhD, Seoul National University Hospital

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 (Actual)

March 12, 2018

Primary Completion (Actual)

January 7, 2021

Study Completion (Actual)

August 22, 2022

Study Registration Dates

First Submitted

November 24, 2017

First Submitted That Met QC Criteria

November 24, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBD-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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