- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05164809
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Jan Puetzler, medical doctor
- Telefonnummer: 00492518359232
- E-mail: jan.puetzler@ukmuenster.de
Undersøgelse Kontakt Backup
- Navn: Jan Puetzler, edical doctor
- Telefonnummer: 00492518359232
- E-mail: jan.puetzler@ukmuenster.de
Studiesteder
-
-
NRW
-
Münster, NRW, Tyskland, 48151
- Rekruttering
- University Hospital Muenster
-
Kontakt:
- Jan Puetzler, medical doctor
- Telefonnummer: 00492518359232
- E-mail: jan.puetzler@ukmuenster.de
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Tungsten/Teflon +
Dissection with novel electrodes (Tungsten needle electrode + Teflon coated Spatula electrode)
|
Application of novel electrodes since 2017 for the dissection of extremity tumors in tumororthopedics
|
|
Tungsten/Teflon -
Dissection without novel electrodes (Scalpel + Steel Spatula Electrode)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood loss
Tidsramme: during surgery
|
monitored during surgery in the anaesthesiology protocol
|
during surgery
|
|
Transfusion of red packed blood cells
Tidsramme: during surgery
|
number of intraoperative units of packed red blood cells
|
during surgery
|
|
Transfusion of red packed blood cells
Tidsramme: 14 days post surgery
|
number of intraoperative units of packed red blood cells
|
14 days post surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
post surgical wound drainage
Tidsramme: 5 days post surgey
|
assessed via recorded volume
|
5 days post surgey
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202101
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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