Clinical trial NCT05164809: Effect of Electrosurgery on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Loss, Surgical
Transfusion Rate
Electrosurgery
Tumororthopaedics
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A defined number of cases is available. All patients with tumor resection and replacement with tumor prosthesis in the orthopedic department at UKM (2012-2016 with conventional dissection instruments and 2018-2021 with novel electrodes) from one single surgeon with over 25 years experience

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients who received hemipelvectomy, hip disarticulation, or major tumor prosthesis implantation at our hospital between 2010 and 2021
* Operated by one single surgeon

Exclusion Criteria:

- Implantation of a Megaprosthesis without history of tumor

Primary outcomes:
measure: Blood loss
timeFrame: during surgery
measure: Transfusion of red packed blood cells
timeFrame: during surgery
measure: Transfusion of red packed blood cells
timeFrame: 14 days post surgery
Secondary outcomes:
measure: post surgical wound drainage
timeFrame: 5 days post surgey
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Muenster
state: NRW
Study officials:
References: