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

NCT05164809 | Unknown

• 1 other identifier: 202101
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss, Surgical; Transfusion Rate; Electrosurgery; Tumororthopaedics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• post surgical wound drainage

  5 days post surgey

Study Arms (2)

Tungsten/Teflon +

Dissection with novel electrodes (Tungsten needle electrode + Teflon coated Spatula electrode)

Device: Application of novel electrodes

Tungsten/Teflon -

Dissection without novel electrodes (Scalpel + Steel Spatula Electrode)

Interventions

Application of novel electrodes DEVICE

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

Tungsten/Teflon +

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• \- Implantation of a Megaprosthesis without history of tumor

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, North Rhine-Westphalia, 48151, Germany

RECRUITING

Related Publications (1)

• Puetzler J, Steinbicker AU, Santel J, Deventer N, Jahn M, Zarbock A, Gosheger G, Schulze M, Jenke DJ. Blood-saving dissection with monopolar tungsten needle electrodes and Teflon-coated spatula electrodes in tumor orthopedics. J Orthop Traumatol. 2023 May 15;24(1):22. doi: 10.1186/s10195-023-00704-8.

  PMID: 37188890 DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical; Hyperthermia

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Central Study Contacts

Jan Puetzler, Medical doctor

CONTACT

00492518359232; jan.puetzler@ukmuenster.de

Jan Puetzler, edical doctor

CONTACT

00492518359232; jan.puetzler@ukmuenster.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, principal investigator

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 21, 2021
• Study Start: October 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)