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

Sponsor
University Hospital Muenster (Other)
Overall Status
Recruiting
CT.gov ID
NCT05164809
Collaborator
(none)
150
1
4
37.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Blood loss [during surgery]

    monitored during surgery in the anaesthesiology protocol

  2. Transfusion of red packed blood cells [during surgery]

    number of intraoperative units of packed red blood cells

  3. Transfusion of red packed blood cells [14 days post surgery]

    number of intraoperative units of packed red blood cells

Secondary Outcome Measures

  1. post surgical wound drainage [5 days post surgey]

    assessed via recorded volume

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Muenster Münster NRW Germany 48151

Sponsors and Collaborators

  • University Hospital Muenster

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jan Puetzler, medical doctor, principal investigator, University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT05164809
Other Study ID Numbers:
  • 202101
First Posted:
Dec 21, 2021
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2022