Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

Postoperative Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356626
• Other study ID #: EBD-02
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: August 22, 2022

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: August 22, 2022
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Postoperative Fever
• Postoperative Inflammation

Intervention

Device:
• ULTRACISION Harmonic Scalpel
to use ULTRACISION Harmonic Scalpel when performing gastrectomy
• Ligasure Maryland
to use Ligasure Maryland when performing gastrectomy
• Thunderbeat
to use Thunderbeat when performing gastrectomy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Medtronic Spine LLC

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative 2nd day CRP	To check the postoperative 2nd day CRP level in each group	2nd day
Secondary	postoperative 4th day CRP	To check the postoperative 4th day CRP level in each group	4th day
Secondary	postoperative IL-6, IL10 level	To check the postoperative 2nd, 4th day IL-6, IL10 level in each group	2nd, 4th day