Effect of Electrosurgery on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery

Blood Loss, Surgical Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164809
• Other study ID #: 202101
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: February 2022

Study information

• Verified date: January 2022
• Source: University Hospital Muenster
• Contact: Jan Puetzler, Medical doctor
• Phone: 00492518359232
• Email: jan.puetzler[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage

Intervention

Device:
• Application of novel electrodes
Application of novel electrodes since 2017 for the dissection of extremity tumors in tumororthopedics

Locations

Country	Name	City	State
Germany	University Hospital Muenster	Münster	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	monitored during surgery in the anaesthesiology protocol	during surgery
Primary	Transfusion of red packed blood cells	number of intraoperative units of packed red blood cells	during surgery
Primary	Transfusion of red packed blood cells	number of intraoperative units of packed red blood cells	14 days post surgery
Secondary	post surgical wound drainage	assessed via recorded volume	5 days post surgey