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Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03356626
Enrollment
189
Registered
2017-11-29
Start date
2018-03-12
Completion date
2022-08-22
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Inflammation, Postoperative Fever

Keywords

fever, inflammation

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

Interventions

DEVICEULTRACISION Harmonic Scalpel

to use ULTRACISION Harmonic Scalpel when performing gastrectomy

DEVICELigasure Maryland

to use Ligasure Maryland when performing gastrectomy

DEVICEThunderbeat

to use Thunderbeat when performing gastrectomy

Sponsors

Medtronic Spine LLC
CollaboratorINDUSTRY
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative 2nd Day CRP2nd dayTo check the postoperative 2nd day CRP level in each group

Secondary

MeasureTime frameDescription
Postoperative 4th Day CRP4th dayTo check the postoperative 4th day CRP level in each group
Postoperative 2nd Day IL-62nd dayTo check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Postoperative 4th Day IL-64th dayTo check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Postoperative 2nd Day IL-10 Level2nd dayTo check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Postoperative 4th Day IL-10 Level4th dayTo check the postoperative 2nd, 4th day IL-6, IL10 level in each group

Countries

South Korea

Participant flow

Participants by arm

ArmCount
ULTRACISION Harmonic Scalpel
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy ULTRACISION Harmonic Scalpel: to use ULTRACISION Harmonic Scalpel when performing gastrectomy
57
Ligasure Maryland
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy
60
Thunderbeat
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy
57
Total174

Baseline characteristics

CharacteristicULTRACISION Harmonic ScalpelLigasure MarylandThunderbeatTotal
Age, Continuous60.75 years
STANDARD_DEVIATION 11.01
60.35 years
STANDARD_DEVIATION 11.01
62.51 years
STANDARD_DEVIATION 10
61 years
STANDARD_DEVIATION 10.67
Preoperative CRP level0.21 mg/dL
STANDARD_DEVIATION 0.18
0.16 mg/dL
STANDARD_DEVIATION 0.16
0.16 mg/dL
STANDARD_DEVIATION 0.14
0.18 mg/dL
STANDARD_DEVIATION 0.16
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
57 Participants60 Participants57 Participants174 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
South Korea
57 participants60 participants57 participants174 participants
Sex: Female, Male
Female
12 Participants26 Participants14 Participants52 Participants
Sex: Female, Male
Male
45 Participants34 Participants43 Participants122 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 570 / 600 / 57
other
Total, other adverse events
2 / 573 / 604 / 57
serious
Total, serious adverse events
0 / 570 / 600 / 57

Outcome results

Primary

Postoperative 2nd Day CRP

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

Time frame: 2nd day

ArmMeasureValue (MEAN)Dispersion
ULTRACISION Harmonic ScalpelPostoperative 2nd Day CRP11.12 mg/dLStandard Deviation 5.02
Ligasure MarylandPostoperative 2nd Day CRP9.03 mg/dLStandard Deviation 5.55
ThunderbeatPostoperative 2nd Day CRP12.67 mg/dLStandard Deviation 6.14
Secondary

Postoperative 2nd Day IL-10 Level

To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

Time frame: 2nd day

ArmMeasureValue (MEAN)Dispersion
ULTRACISION Harmonic ScalpelPostoperative 2nd Day IL-10 Level3.52 pg/mlStandard Deviation 0.04
Ligasure MarylandPostoperative 2nd Day IL-10 Level3.53 pg/mlStandard Deviation 0.04
ThunderbeatPostoperative 2nd Day IL-10 Level3.49 pg/mlStandard Deviation 0.04
Secondary

Postoperative 2nd Day IL-6

To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

Time frame: 2nd day

ArmMeasureValue (MEAN)Dispersion
ULTRACISION Harmonic ScalpelPostoperative 2nd Day IL-617.96 pg/mlStandard Deviation 3.82
Ligasure MarylandPostoperative 2nd Day IL-619.32 pg/mlStandard Deviation 3.51
ThunderbeatPostoperative 2nd Day IL-622.3 pg/mlStandard Deviation 3.61
Secondary

Postoperative 4th Day CRP

To check the postoperative 4th day CRP level in each group

Time frame: 4th day

ArmMeasureValue (MEAN)Dispersion
ULTRACISION Harmonic ScalpelPostoperative 4th Day CRP9.62 mg/dLStandard Deviation 0.53
Ligasure MarylandPostoperative 4th Day CRP7.48 mg/dLStandard Deviation 0.52
ThunderbeatPostoperative 4th Day CRP9.48 mg/dLStandard Deviation 0.53
Secondary

Postoperative 4th Day IL-10 Level

To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

Time frame: 4th day

ArmMeasureValue (MEAN)Dispersion
ULTRACISION Harmonic ScalpelPostoperative 4th Day IL-10 Level0.47 pg/mlStandard Deviation 0.71
Ligasure MarylandPostoperative 4th Day IL-10 Level0.47 pg/mlStandard Deviation 0.71
ThunderbeatPostoperative 4th Day IL-10 Level0.52 pg/mlStandard Deviation 0.66
Secondary

Postoperative 4th Day IL-6

To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

Time frame: 4th day

ArmMeasureValue (MEAN)Dispersion
ULTRACISION Harmonic ScalpelPostoperative 4th Day IL-68.08 pg/mlStandard Deviation 3.82
Ligasure MarylandPostoperative 4th Day IL-68.07 pg/mlStandard Deviation 3.62
ThunderbeatPostoperative 4th Day IL-67.16 pg/mlStandard Deviation 3.61

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026