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Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy
NA trial testing ULTRACISION Harmonic Scalpel in Postoperative Inflammation in 189 participants. Completed in 22 August 2022.
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 189 |
| Start date | 12 March 2018 |
| Primary completion | 7 January 2021 |
| Estimated completion | 22 August 2022 |
| Sites | 1 location across South Korea |
Seoul National University Hospital
Adults 20 to 80, any sex, with Postoperative Inflammation or Postoperative Fever. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To check the postoperative 2nd day CRP level in each group
| Group | Value | 95% CI |
|---|---|---|
| ULTRACISION Harmonic Scalpel | 11.12 | ± 5.02 |
| Ligasure Maryland | 9.03 | ± 5.55 |
| Thunderbeat | 12.67 | ± 6.14 |
To check the postoperative 4th day CRP level in each group
| Group | Value | 95% CI |
|---|---|---|
| ULTRACISION Harmonic Scalpel | 9.62 | ± 0.53 |
| Ligasure Maryland | 7.48 | ± 0.52 |
| Thunderbeat | 9.48 | ± 0.53 |
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
| Group | Value | 95% CI |
|---|---|---|
| ULTRACISION Harmonic Scalpel | 17.96 | ± 3.82 |
| Ligasure Maryland | 19.32 | ± 3.51 |
| Thunderbeat | 22.3 | ± 3.61 |
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
| Group | Value | 95% CI |
|---|---|---|
| ULTRACISION Harmonic Scalpel | 8.08 | ± 3.82 |
| Ligasure Maryland | 8.07 | ± 3.62 |
| Thunderbeat | 7.16 | ± 3.61 |
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
| Group | Value | 95% CI |
|---|---|---|
| ULTRACISION Harmonic Scalpel | 3.52 | ± 0.04 |
| Ligasure Maryland | 3.53 | ± 0.04 |
| Thunderbeat | 3.49 | ± 0.04 |
To check the postoperative 2nd, 4th day IL-6, IL10 level in each group
| Group | Value | 95% CI |
|---|---|---|
| ULTRACISION Harmonic Scalpel | 0.47 | ± 0.71 |
| Ligasure Maryland | 0.47 | ± 0.71 |
| Thunderbeat | 0.52 | ± 0.66 |
Time frame: 30 days after operation. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ULTRACISION Harmonic Scalpel | Ligasure Maryland | Thunderbeat |
|---|---|---|---|---|
| Postoperative complication: Clavien-Dindo grade ≥ IIIa † | Gastrointestinal disorders | — | — | — |
| Postoperative complication: Clavien-Dindo grade < IIIa | Gastrointestinal disorders | — | — | — |
Data from ClinicalTrials.gov NCT03356626 adverse events section.
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
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing