Trial Outcomes & Findings for Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy (NCT NCT03356626)
NCT ID: NCT03356626
Last Updated: 2024-09-23
Results Overview
To check the postoperative 2nd day CRP level in each group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
189 participants
Primary outcome timeframe
2nd day
Results posted on
2024-09-23
Participant Flow
Participant milestones
| Measure |
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
|
Ligasure Maryland
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy
|
Thunderbeat
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
65
|
63
|
|
Overall Study
COMPLETED
|
57
|
60
|
57
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy
Baseline characteristics by cohort
| Measure |
ULTRACISION Harmonic Scalpel
n=57 Participants
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy ULTRACISION Harmonic Scalpel: to use ULTRACISION Harmonic Scalpel when performing gastrectomy
|
Ligasure Maryland
n=60 Participants
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy
|
Thunderbeat
n=57 Participants
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.75 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
60.35 years
STANDARD_DEVIATION 11.01 • n=7 Participants
|
62.51 years
STANDARD_DEVIATION 10.00 • n=5 Participants
|
61 years
STANDARD_DEVIATION 10.67 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
57 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
57 participants
n=5 Participants
|
60 participants
n=7 Participants
|
57 participants
n=5 Participants
|
174 participants
n=4 Participants
|
|
Preoperative CRP level
|
0.21 mg/dL
STANDARD_DEVIATION 0.18 • n=5 Participants
|
0.16 mg/dL
STANDARD_DEVIATION 0.16 • n=7 Participants
|
0.16 mg/dL
STANDARD_DEVIATION 0.14 • n=5 Participants
|
0.18 mg/dL
STANDARD_DEVIATION 0.16 • n=4 Participants
|
PRIMARY outcome
Timeframe: 2nd dayTo check the postoperative 2nd day CRP level in each group
Outcome measures
| Measure |
ULTRACISION Harmonic Scalpel
n=57 Participants
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy ULTRACISION Harmonic Scalpel: to use ULTRACISION Harmonic Scalpel when performing gastrectomy
|
Ligasure Maryland
n=60 Participants
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy
|
Thunderbeat
n=57 Participants
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy
|
|---|---|---|---|
|
Postoperative 2nd Day CRP
|
11.12 mg/dL
Standard Deviation 5.02
|
9.03 mg/dL
Standard Deviation 5.55
|
12.67 mg/dL
Standard Deviation 6.14
|
SECONDARY outcome
Timeframe: 4th dayTo check the postoperative 4th day CRP level in each group
Outcome measures
| Measure |
ULTRACISION Harmonic Scalpel
n=57 Participants
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy ULTRACISION Harmonic Scalpel: to use ULTRACISION Harmonic Scalpel when performing gastrectomy
|
Ligasure Maryland
n=60 Participants
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy
|
Thunderbeat
n=57 Participants
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy
|
|---|---|---|---|
|
Postoperative 4th Day CRP
|
9.62 mg/dL
Standard Deviation 0.53
|
7.48 mg/dL
Standard Deviation 0.52
|
9.48 mg/dL
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 2nd dayTo check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Outcome measures
| Measure |
ULTRACISION Harmonic Scalpel
n=57 Participants
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy ULTRACISION Harmonic Scalpel: to use ULTRACISION Harmonic Scalpel when performing gastrectomy
|
Ligasure Maryland
n=60 Participants
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy
|
Thunderbeat
n=57 Participants
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy
|
|---|---|---|---|
|
Postoperative 2nd Day IL-6
|
17.96 pg/ml
Standard Deviation 3.82
|
19.32 pg/ml
Standard Deviation 3.51
|
22.3 pg/ml
Standard Deviation 3.61
|
SECONDARY outcome
Timeframe: 4th dayTo check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Outcome measures
| Measure |
ULTRACISION Harmonic Scalpel
n=57 Participants
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy ULTRACISION Harmonic Scalpel: to use ULTRACISION Harmonic Scalpel when performing gastrectomy
|
Ligasure Maryland
n=60 Participants
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy
|
Thunderbeat
n=57 Participants
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy
|
|---|---|---|---|
|
Postoperative 4th Day IL-6
|
8.08 pg/ml
Standard Deviation 3.82
|
8.07 pg/ml
Standard Deviation 3.62
|
7.16 pg/ml
Standard Deviation 3.61
|
SECONDARY outcome
Timeframe: 2nd dayTo check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Outcome measures
| Measure |
ULTRACISION Harmonic Scalpel
n=57 Participants
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy ULTRACISION Harmonic Scalpel: to use ULTRACISION Harmonic Scalpel when performing gastrectomy
|
Ligasure Maryland
n=60 Participants
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy
|
Thunderbeat
n=57 Participants
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy
|
|---|---|---|---|
|
Postoperative 2nd Day IL-10 Level
|
3.52 pg/ml
Standard Deviation 0.04
|
3.53 pg/ml
Standard Deviation 0.04
|
3.49 pg/ml
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: 4th dayTo check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Outcome measures
| Measure |
ULTRACISION Harmonic Scalpel
n=57 Participants
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy ULTRACISION Harmonic Scalpel: to use ULTRACISION Harmonic Scalpel when performing gastrectomy
|
Ligasure Maryland
n=60 Participants
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy
|
Thunderbeat
n=57 Participants
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy
|
|---|---|---|---|
|
Postoperative 4th Day IL-10 Level
|
0.47 pg/ml
Standard Deviation 0.71
|
0.47 pg/ml
Standard Deviation 0.71
|
0.52 pg/ml
Standard Deviation 0.66
|
Adverse Events
ULTRACISION Harmonic Scalpel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ligasure Maryland
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Thunderbeat
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ULTRACISION Harmonic Scalpel
n=57 participants at risk
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy ULTRACISION Harmonic Scalpel: to use ULTRACISION Harmonic Scalpel when performing gastrectomy
|
Ligasure Maryland
n=60 participants at risk
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy Ligasure Maryland: to use Ligasure Maryland when performing gastrectomy
|
Thunderbeat
n=57 participants at risk
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy Thunderbeat: to use Thunderbeat when performing gastrectomy
|
|---|---|---|---|
|
Gastrointestinal disorders
Postoperative complication: Clavien-Dindo grade < IIIa
|
1.8%
1/57 • Number of events 1 • 30 days after operation
|
3.3%
2/60 • Number of events 2 • 30 days after operation
|
1.8%
1/57 • Number of events 1 • 30 days after operation
|
|
Gastrointestinal disorders
Postoperative complication: Clavien-Dindo grade ≥ IIIa †
|
1.8%
1/57 • Number of events 1 • 30 days after operation
|
1.7%
1/60 • Number of events 1 • 30 days after operation
|
5.3%
3/57 • Number of events 3 • 30 days after operation
|
Additional Information
Seong-Ho Kong
Seoul National University Hospital, Seoul National University College of Medicine
Phone: +82-2-2072-4199
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place