Trials / Unknown
UnknownNCT05164809
Effect of Electrosurgery on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery
Effect of Monopolar Tungsten Needle Electrodes and Teflon Coated Spatula Electrodes on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery Compared to Conventional Surgical Knives and Stainless-Steel Electrodes
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- University Hospital Muenster · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Resection of malign musculoskeletal tumors and reconstruction with large tumor prostheses often results in relevant blood loss requiring hemodynamic stabilization and transfusion. The use of novel electrosurgical electrodes is assessed retrospectively regarding the potential to reduce blood loss and the need for transfusions.
Detailed description
Background Resection of malign musculoskeletal tumors and reconstruction with large tumor prostheses often result in relevant blood loss requiring hemodynamic stabilization and transfusion. Since machine autotransfusion is contraindicated in tumor surgery, other measures are necessary to reduce intraoperative blood loss. Objectives Tungsten needle electrodes can be used to simultaneously cut skin and seal bleeding vessels for superficial dissection. Spatula electrodes coated with Teflon (polytetrafluoroethylene PTFE) are used for coagulation and dissection of deeper tissues. The coating reduces eschar build-up and thus smoke creation compared to conventional stainless-steel electrodes. This study assesses the effect of these novel electrodes on blood loss and transfusion rates. Methods: The investigators retrospectively investigate all cases of tumor resection and reconstruction with tumor prostheses that were operated five years before the introduction of the new electrodes (2012-2016) and five years after (2018-2021) by one single surgeon with over 25 years of experience. Data are extracted from digital patient records and analyzed by descriptive statistics and t-test for normally distributed data or Mann-Whitney test in case of non-normal distribution.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Application of novel electrodes | Application of novel electrodes since 2017 for the dissection of extremity tumors in tumororthopedics |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2022-01-01
- Completion
- 2022-02-01
- First posted
- 2021-12-21
- Last updated
- 2022-01-18
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05164809. Inclusion in this directory is not an endorsement.