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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Wang, Xipeng Li, Chengqiang Fan, Junqiang Hu, Jian Wang, Mingsong Li, Hecheng |
| Abstract | Background The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5–7 mm blood vessels in thoracic surgery. Methods This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed. Discussion This clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5–7 mm blood vessels in thoracic surgery. Trial registration ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www.clinicaltrials.gov/study/NCT06002737 . |
| Related Links | https://bmcsurg.biomedcentral.com/counter/pdf/10.1186/s12893-024-02497-x.pdf |
| Ending Page | 6 |
| Page Count | 6 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 14712482 |
| DOI | 10.1186/s12893-024-02497-x |
| Journal | BMC Surgery |
| Issue Number | 1 |
| Volume Number | 24 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2024-07-19 |
| Access Restriction | Open |
| Subject Keyword | Surgery Internal Medicine Disposable Ultrasonic shears Surgical instruments 5-7 mm blood vessels Thoracic surgery |
| Content Type | Text |
| Resource Type | Article |
| Subject | Surgery |
| Journal Impact Factor | 1.6/2023 |
| 5-Year Journal Impact Factor | 1.9/2023 |
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