Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis (Harmonic)
June 24, 2010 updated by: University of Cologne
Comparison of the Quantity of Bleeding and the Duration of Operation in Thoracoscopic Ventral Spondylodesis During Preparation With Monopolar Electrosurgery Compared to Ultrasound Scissors.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Cologne, NRW, Germany, 50924
- Recruiting
- University of Cologne, Department of Orthopaedics/Trauma surgery
-
Principal Investigator:
- Peer Eysel, Professor
-
Sub-Investigator:
- Gereon Schiffer
-
Sub-Investigator:
- Ulrich Thelen, MD
-
Sub-Investigator:
- Timmo Koy, MD
-
Sub-Investigator:
- Koroush Zarghooni, MD
-
Sub-Investigator:
- Thomas Kaulhausen, MD
-
Sub-Investigator:
- Jan Siewe, MD
-
Sub-Investigator:
- Henning Kunter, MD
-
Sub-Investigator:
- Christina Otto, MD
-
Sub-Investigator:
- Bergita Ganse, MD
-
Cologne, NRW, Germany, 58448
- Not yet recruiting
- Kliniken der Stadt Köln gGmbH Merheim
-
Principal Investigator:
- Dieter Rixen, Professor
-
Sub-Investigator:
- Thomas Paffrath, MD
-
Sub-Investigator:
- Thorsten Tjardes, MD
-
Sub-Investigator:
- Eva Steinhausen, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Monopolar Electrosurgery
Preparation during the operation with Monopolar Electrosurgery
|
preparation with electroscalpel during operation
Other Names:
|
|
EXPERIMENTAL: Ultrasound scissors
Preparation during the operation with ultrasound scissors
|
preparation with ultrasound scissors during operation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
duration of the operation
Time Frame: end of the scin suture at the end of operation
|
end of the scin suture at the end of operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
loss of blood during operation and at first day after the operation
Time Frame: 24 hours after end of operation
|
24 hours after end of operation
|
|
length of stay at the hospital
Time Frame: day of discharge from hospitalization
|
day of discharge from hospitalization
|
|
trauma of internal organs during operation
Time Frame: end of the scin suure at the end of operation
|
end of the scin suure at the end of operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Peer Eysel, Professor, University of Cologne, Department of Orthopaedics/Trauma surgery
- Principal Investigator: Gereon Schiffer, MD, University of Cologne, Department of Orthopaedics/Trauma surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (ANTICIPATED)
August 1, 2011
Study Completion (ANTICIPATED)
August 1, 2011
Study Registration Dates
First Submitted
June 15, 2009
First Submitted That Met QC Criteria
July 16, 2009
First Posted (ESTIMATE)
July 17, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 25, 2010
Last Update Submitted That Met QC Criteria
June 24, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uni-Koeln-1235
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.