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| ID | Type | Description | Link |
|---|---|---|---|
| Uni-Koeln-1235 |
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| Name | Class |
|---|---|
| Ethicon Endo-Surgery (Europe) GmbH | INDUSTRY |
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This study was undertaken to investigate the effect of using ultrasound scissors in the preparation for Thoracoscopic Ventral Spondylodesis. Quantity of bleeding and the duration of operation in Thoracoscopic Ventral Spondylodesis are compared to the preparation with monopolar electrosurgery.
One group of patients will be operated on using ultrasound scissors in the preparation during Thoracoscopic Ventral Spondylodesis. The other group will be operated on using Monopolar Electrosurgery.
The study is designed as a randomized trial. That means that all patients who have given their consent to participate in the study will be allocated to either ultrasound scissors or Monopolar Electrosurgery by chance.
A total of 40 patients will be included in this study. The study ends with finishing of the first day after the operation, there is no longer follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monopolar Electrosurgery | Active Comparator | Preparation during the operation with Monopolar Electrosurgery |
|
| Ultrasound scissors | Experimental | Preparation during the operation with ultrasound scissors |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound scissors - Harmonic ACE | Device | preparation with ultrasound scissors during operation |
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| Measure | Description | Time Frame |
|---|---|---|
| duration of the operation | end of the scin suture at the end of operation |
| Measure | Description | Time Frame |
|---|---|---|
| loss of blood during operation and at first day after the operation | 24 hours after end of operation | |
| length of stay at the hospital | day of discharge from hospitalization | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Otto, MD | Contact | +49 221 478 86973 | christina.otto@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Peer Eysel, Professor | University of Cologne, Department of Orthopaedics/Trauma surgery | Study Director |
| Gereon Schiffer, MD | University of Cologne, Department of Orthopaedics/Trauma surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cologne, Department of Orthopaedics/Trauma surgery | Recruiting | Cologne | North Rhine-Westphalia | 50924 | Germany |
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| electroscalpel (Erbe Vio 300; Aesculap AG) | Device | preparation with electroscalpel during operation |
|
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| trauma of internal organs during operation |
| end of the scin suure at the end of operation |
| Kliniken der Stadt Köln gGmbH Merheim | Not yet recruiting | Cologne | North Rhine-Westphalia | 58448 | Germany |
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