Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of the Quantity of Bleeding and the Duration of Operation in Thoracoscopic Ventral Spondylodesis During Preparation With Monopolar Electrosurgery Compared to Ultrasound Scissors.

Conditions
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Fractures of Vertebral Bodies

Intervention / Treatment
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* Device: ultrasound scissors - Harmonic ACE
* Device: electroscalpel (Erbe Vio 300; Aesculap AG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent fracture of vertebral bodies Th10-L2 with indication for operative treatment Exclusion Criteria: missing informed consent mission indication for operative treatment revision of the trailing edge clotting inhibition therapy ASA III/IV pregnancy malfunction of liver Child C

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monopolar Electrosurgery<br>Preparation during the operation with Monopolar Electrosurgery | Device: electroscalpel (Erbe Vio 300; Aesculap AG)<br>* preparation with electroscalpel during operation<br>* Other names: Generator Erbe Vio 300, hook from Aesculap AG;|
| Experimental: Ultrasound scissors<br>Preparation during the operation with ultrasound scissors | Device: ultrasound scissors - Harmonic ACE<br>* preparation with ultrasound scissors during operation<br>* Other names: Harmonic ACE; Firma Ethicon Endo-Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the operation |  | end of the scin suture at the end of operation | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| trauma of internal organs during operation |  | end of the scin suure at the end of operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractures of vertebral bodies Th10-L2, (AO A1 with kyphosis, A2.3, B or C-type)