Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

Not Applicable

Completed

• Conditions: Postoperative Inflammation; Postoperative Fever
• Interventions: Device: Ligasure Maryland; Device: ULTRACISION Harmonic Scalpel; Device: Thunderbeat

• Registration Number: NCT03356626
• Lead Sponsor: Seoul National University Hospital

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

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 Timeline

• Study First Submitted: 2017-11-24
• Study First Submitted QC: 2017-11-24
• Study First Posted: 2017-11-29
• Study Start: 2018-03-12
• Primary Completion: 2021-01-07
• Status Verified: 2022-05
• Study Completion: 2022-08-22
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ligasure Maryland	Ligasure Maryland	Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy
ULTRACISION Harmonic Scalpel	ULTRACISION Harmonic Scalpel	Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy
Thunderbeat	Thunderbeat	Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy

Primary Outcome Measures

Name	Time	Method
Postoperative 2nd Day CRP	2nd day	To check the postoperative 2nd day CRP level in each group

Secondary Outcome Measures

Name	Time	Method
Postoperative 4th Day CRP	4th day	To check the postoperative 4th day CRP level in each group
Postoperative 2nd Day IL-6	2nd day	To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Postoperative 4th Day IL-6	4th day	To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Postoperative 2nd Day IL-10 Level	2nd day	To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Postoperative 4th Day IL-10 Level	4th day	To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of