JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05164809

Studienbeginn:
Oktober 2021

Letztes Update:
18.01.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Hemorrhage, Blood Loss, Surgical

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Muenster

Collaborator:
-

Kontakt

Jan Puetzler, Medical doctor
Kontakt:
Phone: 00492518359232
E-Mail: jan.puetzler@ukmuenster.de» Kontaktdaten anzeigen

Jan Puetzler, edical doctor
Kontakt:
Phone: 00492518359232
E-Mail: jan.puetzler@ukmuenster.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Muenster
48151 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jan Puetzler, medical doctor
Phone: 00492518359232
E-Mail: jan.puetzler@ukmuenster.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Blood loss (Time Frame - during surgery):
monitored during surgery in the anaesthesiology protocol

2. Transfusion of red packed blood cells (Time Frame - during surgery):
number of intraoperative units of packed red blood cells

3. Transfusion of red packed blood cells (Time Frame - 14 days post surgery):
number of intraoperative units of packed red blood cells

Secondary outcome:

1. post surgical wound drainage (Time Frame - 5 days post surgey):
assessed via recorded volume

Studien-Arme

Tungsten/Teflon +
Dissection with novel electrodes (Tungsten needle electrode + Teflon coated Spatula electrode)
Tungsten/Teflon -
Dissection without novel electrodes (Scalpel + Steel Spatula Electrode)

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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

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