An interventional study of ULTRACISION Harmonic Scalpel and Ligasure Maryland in Postoperative Inflammation and Postoperative Fever, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic
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
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
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's enrollment of 189 is above the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy
Device: ULTRACISION Harmonic Scalpel
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy
Device: Ligasure Maryland
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy
Device: Thunderbeat
to use ULTRACISION Harmonic Scalpel when performing gastrectomy
to use Ligasure Maryland when performing gastrectomy
to use Thunderbeat when performing gastrectomy
Postoperative 2nd Day CRP
To check the postoperative 2nd day CRP level in each group
Time frame: 2nd day
Postoperative 4th Day CRP
To check the postoperative 4th day CRP level in each group
Time frame: 4th day
Postoperative 2nd Day IL-6
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Time frame: 2nd day
Postoperative 4th Day IL-6
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Time frame: 4th day
Postoperative 2nd Day IL-10 Level
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Time frame: 2nd day
Postoperative 4th Day IL-10 Level
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
Time frame: 4th day
| Milestone | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat |
|---|---|---|---|
| Started | 61 | 65 | 63 |
| Completed | 57 | 60 | 57 |
| Not completed | 4 | 5 | 6 |
To check the postoperative 2nd day CRP level in each group
| mg/dL | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat |
|---|---|---|---|
| Postoperative 2nd Day CRP | 11.12 ± 5.02 | 9.03 ± 5.55 | 12.67 ± 6.14 |
To check the postoperative 4th day CRP level in each group
| mg/dL | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat |
|---|---|---|---|
| Postoperative 4th Day CRP | 9.62 ± 0.53 | 7.48 ± 0.52 | 9.48 ± 0.53 |
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
| pg/ml | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat |
|---|---|---|---|
| Postoperative 2nd Day IL-6 | 17.96 ± 3.82 | 19.32 ± 3.51 | 22.3 ± 3.61 |
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
| pg/ml | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat |
|---|---|---|---|
| Postoperative 4th Day IL-6 | 8.08 ± 3.82 | 8.07 ± 3.62 | 7.16 ± 3.61 |
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
| pg/ml | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat |
|---|---|---|---|
| Postoperative 2nd Day IL-10 Level | 3.52 ± 0.04 | 3.53 ± 0.04 | 3.49 ± 0.04 |
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
| pg/ml | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat |
|---|---|---|---|
| Postoperative 4th Day IL-10 Level | 0.47 ± 0.71 | 0.47 ± 0.71 | 0.52 ± 0.66 |
Collected over 30 days after operation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ULTRACISION Harmonic Scalpel | 0/57 (0%) | 0/57 (0%) | 2/57 (3.5%) |
| Ligasure Maryland | 0/60 (0%) | 0/60 (0%) | 3/60 (5%) |
| Thunderbeat | 0/57 (0%) | 0/57 (0%) | 4/57 (7%) |
| Event | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat |
|---|---|---|---|
| Postoperative complication: Clavien-Dindo grade ≥ IIIa †Gastrointestinal disorders | 1/57 | 1/60 | 3/57 |
| Postoperative complication: Clavien-Dindo grade < IIIaGastrointestinal disorders | 1/57 | 2/60 | 1/57 |
| Age, Continuous(years) | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat | Total |
|---|---|---|---|---|
| Mean | 60.75 ± 11.01 | 60.35 ± 11.01 | 62.51 ± 10.00 | 61 ± 10.67 |
| Sex: Female, Male(Participants) | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat | Total |
|---|---|---|---|---|
| Female | 12 | 26 | 14 | 52 |
| Male | 45 | 34 | 43 | 122 |
| Race (NIH/OMB)(Participants) | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 57 | 60 | 57 | 174 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat | Total |
|---|---|---|---|---|
| South Korea | 57 | 60 | 57 | 174 |
| Preoperative CRP level(mg/dL) | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat | Total |
|---|---|---|---|---|
| Mean | 0.21 ± 0.18 | 0.16 ± 0.16 | 0.16 ± 0.14 | 0.18 ± 0.16 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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