Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

NCT03356626 | Completed Results

• 1 other identifier: EBD-02
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Inflammation; Postoperative Fever

Keywords

fever, inflammation

Outcome Measures

Primary Outcomes (1)

• Postoperative 2nd Day CRP

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

  2nd day

Secondary Outcomes (5)

• Postoperative 4th Day CRP

  4th day

• Postoperative 2nd Day IL-6

  2nd day

• Postoperative 4th Day IL-6

  4th day

• Postoperative 2nd Day IL-10 Level

  2nd day

• Postoperative 4th Day IL-10 Level

  4th day

Study Arms (3)

ULTRACISION Harmonic Scalpel

EXPERIMENTAL

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

Device: ULTRACISION Harmonic Scalpel

Ligasure Maryland

EXPERIMENTAL

Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy

Device: Ligasure Maryland

Thunderbeat

EXPERIMENTAL

Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy

Device: Thunderbeat

Interventions

ULTRACISION Harmonic Scalpel DEVICE

to use ULTRACISION Harmonic Scalpel when performing gastrectomy

ULTRACISION Harmonic Scalpel

Ligasure Maryland DEVICE

to use Ligasure Maryland when performing gastrectomy

Ligasure Maryland

Thunderbeat DEVICE

to use Thunderbeat when performing gastrectomy

Thunderbeat

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Medtronic Spine LLC: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Fever; Inflammation

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Limitations and Caveats

The complication rate, could not be evaluated due to the limited number of cases. A stratified randomization method was chosen in this study to prevent an imbalance of prognostic factors that could affect the results, but the baseline characteristics of the patients in each group were not perfectly balanced. Since gastric surgery may be affected by patient factors, such as sex and BMI, those factors should be considered stratification factors.

Results Point of Contact

• Title: Seong-Ho Kong
• Organization: Seoul National University Hospital, Seoul National University College of Medicine

seongho.kong@snu.ac.kr

+82-2-2072-4199

Study Officials

• Seong-Ho Kong, MD,PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 29, 2017
• Study Start: March 12, 2018
• Primary Completion: January 7, 2021
• Study Completion: August 22, 2022
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2022-05

Locations

KR (1)