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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Loss, Surgical; Transfusion Rate; Electrosurgery; Tumororthopaedics
• Intervention / Treatment: Device: Application of novel electrodes

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Jan Puetzler, medical doctor; Phone Number: 00492518359232; Email: jan.puetzler@ukmuenster.de
• Study Contact Backup: Name: Jan Puetzler, edical doctor; Phone Number: 00492518359232; Email: jan.puetzler@ukmuenster.de

Study Locations

• Germany
  • NRW
    • Münster, NRW, Germany, 48151
      • Recruiting
      • University Hospital Muenster
      • Contact: Jan Puetzler, medical doctor; Phone Number: 00492518359232; Email: jan.puetzler@ukmuenster.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tungsten/Teflon +; Dissection with novel electrodes (Tungsten needle electrode + Teflon coated Spatula electrode)	Device: Application of novel electrodes; Application of novel electrodes since 2017 for the dissection of extremity tumors in tumororthopedics
Tungsten/Teflon -; Dissection without novel electrodes (Scalpel + Steel Spatula Electrode)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	monitored during surgery in the anaesthesiology protocol	during surgery
Transfusion of red packed blood cells	number of intraoperative units of packed red blood cells	during surgery
Transfusion of red packed blood cells	number of intraoperative units of packed red blood cells	14 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post surgical wound drainage	assessed via recorded volume	5 days post surgey

Collaborators and Investigators

• Sponsor: University Hospital Muenster

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 2, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: 202101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No