Blood Loss, SurgicalNCT05164809
Effect of Electrosurgery on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery
An observational study of Blood Loss, Surgical and Transfusion Rate, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Resection of malign musculoskeletal tumors and reconstruction with large tumor prostheses often results in relevant blood loss requiring hemodynamic stabilization and transfusion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Surgical, Transfusion Rate, Electrosurgery
- What is being tested?
- Application of novel electrodes
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2021to Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Patients who received hemipelvectomy, hip disarticulation, or major tumor prosthesis implantation at our hospital between 2010 and 2021
- Operated by one single surgeon
Who cannot join
- Implantation of a Megaprosthesis without history of tumor
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Muenster
Münster, North Rhine-Westphalia, 48151
Jan Puetzler, medical doctor, 00492518359232, jan.puetzler@ukmuenster.de
About this study
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
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.
Read the 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.
- Being tested
- Application of novel electrodes
- Medical subject headings
- Blood Loss, Surgical, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of novel electrodesDevice
Application of novel electrodes since 2017 for the dissection of extremity tumors in tumororthopedics
| Study group | Role | What they receive |
|---|---|---|
| Tungsten/Teflon + | Dissection with novel electrodes (Tungsten needle electrode + Teflon coated Spatula electrode) Receives: Device: Application of novel electrodes | |
| Tungsten/Teflon - | Dissection without novel electrodes (Scalpel + Steel Spatula Electrode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
monitored during surgery in the anaesthesiology protocol
Measured: during surgery
Transfusion of red packed blood cells
number of intraoperative units of packed red blood cells
Measured: during surgery
Transfusion of red packed blood cells
number of intraoperative units of packed red blood cells
Measured: 14 days post surgery
Secondary outcomes (1)
post surgical wound drainage
assessed via recorded volume
Measured: 5 days post surgey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Oct 2021
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Puetzler, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164809
- Sponsor's protocol ID
- 202101
- Status last verified
- Jan 2022
- First submitted
- 19 Nov 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Publications
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.
PubMed 37188890
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05164809
- Acronym / sponsor ID
- 202101
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tungsten/Teflon + | – | Device: Application of novel electrodesDissection with novel electrodes (Tungsten needle electrode + Teflon coated Spatula electrode) |
| Tungsten/Teflon - | – | –Dissection without novel electrodes (Scalpel + Steel Spatula Electrode) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients who received hemipelvectomy, hip disarticulation, or major tumor prosthesis implantation at our hospital between 2010 and 2021
- Operated by one single surgeon
Key exclusion criteria (1 listed)
- Implantation of a Megaprosthesis without history of tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of novel electrodesApplication of novel electrodes since 2017 for the dissection of extremity tumors in tumororthopedics | Device | Tungsten/Teflon + |
Primary outcome
Blood loss
Time frame: during surgery
monitored during surgery in the anaesthesiology protocol
Transfusion of red packed blood cells
Time frame: during surgery
number of intraoperative units of packed red blood cells
Transfusion of red packed blood cells
Time frame: 14 days post surgery
number of intraoperative units of packed red blood cells
1 secondary outcome
post surgical wound drainage
Time frame: 5 days post surgey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Derived from this study: PubMed 37188890Puetzler 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.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss, Surgical and Transfusion Rate, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Puetzler, Medical doctor (00492518359232, jan.puetzler@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: during surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05164809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.