Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis (Harmonic)

University of Cologne

Status and phase: Unknown; Phase 4

Conditions: Fractures of Vertebral Bodies

Treatments: Device: ultrasound scissors - Harmonic ACE; Device: electroscalpel (Erbe Vio 300; Aesculap AG)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00941213

Uni-Koeln-1235

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Monopolar Electrosurgery

Active Comparator group

Description:

Preparation during the operation with Monopolar Electrosurgery

Treatment:

Device: electroscalpel (Erbe Vio 300; Aesculap AG)

Ultrasound scissors

Experimental group

Description:

Preparation during the operation with ultrasound scissors

Treatment:

Device: ultrasound scissors - Harmonic ACE