Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

Seoul National University

Status: Completed

Conditions: Postoperative Inflammation; Postoperative Fever

Treatments: Device: ULTRACISION Harmonic Scalpel; Device: Thunderbeat; Device: Ligasure Maryland

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03356626

EBD-02

Details and patient eligibility

About

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

Full 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

Enrollment: 189 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts 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
• Patients 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
• uncontrolled 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

189 participants in 3 patient groups

ULTRACISION Harmonic Scalpel

Experimental group

Description:

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

Treatment:

Device: ULTRACISION Harmonic Scalpel

Ligasure Maryland

Experimental group

Description:

Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy

Treatment:

Device: Ligasure Maryland

Thunderbeat

Experimental group

Description:

Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy

Treatment:

Device: Thunderbeat