Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation HemostasisNCT03890328
RF-assisted Splenic Preservation VS Conventional Treatment of Blunt Splenic Injury.
A study testing radiofrequency ablation in people with Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis, run by Southwest Hospital, China at 1 site in China.
Trial summary
Radiofrequency (RF) can be used to treat splenic trauma because of its excellent coagulation hemostasis. This study aimed to compare the efficacy of RF-assisted spleen-preserving surgery with that of conventional splenorrhaphy/splenectomy in the treatment of blunt splenic injury. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis
- What is being tested?
- radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2009to 1 Jun 2014
- Phase
- Interventional
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age below 70
- blunt abdominal injury combined with indication of post-traumatic splenectomy according to the guidelines provided by the Society for Surgery of the Alimentary Tract in 2005
- patients transferred directly to the trauma center after injury who had not been treated by any specific spleen-directed therapy in the transferring hospital
- AAST grade II splenic injury with hemodynamic instability or progressive bleeding requiring active intervention
- AAST grade Ⅲ-Ⅳsplenic injury, or splenic laceration involving less than 50% of the splenic parenchyma
Who cannot join
- penetrating abdominal injury
- concomitant organ injury with an abbreviated injury scale (AIS) greater than 4 that threatened the life of the patient
- excessive vascular injury to the splenic pedicle or substantial devitalized splenic tissues when it was expected in when less than 25% of the spleen could be preserved
- patients who had failed NOM
- patients with pathologic splenic rupture
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of hepatobiliary surgery,Southwest Hospital
Chongqing, Chongqing Municipality, 400038
About this study
Official title: Radiofrequency-assisted Splenic Preservation Versus Conventional Treatment of Blunt Splenic Injury: A Prospective Cohort Study.
Radiofrequency (RF) can be used to treat splenic trauma because of its excellent coagulation hemostasis. This study aimed to compare the efficacy of RF-assisted spleen-preserving surgery with that of conventional splenorrhaphy/splenectomy in the treatment of blunt splenic injury.
A total of 122 patients with splenic trauma admitted to two tertiary referral centers from June 2011 to June 2014 were included in this prospective cohort study. The 67 patients at one center were treated by radiofrequency-assisted spleen-preserving therapy (RF group), and the 55 patients admitted at the other center underwent conventional treatment (CT group). Demographics and clinical characteristics of the two groups were comparable.
Compared to traditional splenorrhaphy and splenectomy, RF-assisted splenic hemostasis and salvage was safe, effective and easy to use in the treatment of splenic injuries. In particular for high-grade splenic injuries, these techniques preserved sufficient splenic tissue without any increase in patients with surgical risk.
- Conditions
- Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis
- Being tested
- radiofrequency ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
apply RF therapy to the treatment of splenic trauma
| Study group | Role | What they receive |
|---|---|---|
| RF group | Experimental | radiofrequency-assisted spleen-preserving therapy group. Receives: Procedure: radiofrequency ablation |
| CT group | No intervention | Conventional Treatment of Blunt Splenic Injury group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean operative time，
Mean operative time of the RF group was compared with that of CT group.
Measured: intraoperative
intraoperative bleeding
Intraoperative bleeding of the RF group was compared with that of CT group.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Mar 2009
- Primary completion1 Jun 2014
- Study completion1 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation HemostasisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- West China Second University Hospital
- Responsible party
- Principal investigator, fengkai, Southwest Hospital, China
- Investigators
- Kuansheng Ma, Ph.D, Principal investigator, Institute of hepatobiliary surgery,Southwest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890328
- Sponsor's protocol ID
- 81672857
- Status last verified
- Mar 2009
- First submitted
- 20 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency-assisted Splenic Preservation Versus Conventional Treatment of Blunt Splenic Injury: A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03890328
- Acronym / sponsor ID
- 81672857
- Conditions
- Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Collaborators
- West China Second University Hospital
- Study start
- 1 Mar 2009 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 1 Jun 2014 (actual)
- First posted
- 26 Mar 2019 (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.
Radiofrequency (RF) can be used to treat splenic trauma because of its excellent coagulation hemostasis. This study aimed to compare the efficacy of RF-assisted spleen-preserving surgery with that of conventional splenorrhaphy/splenectomy in the treatment of blunt splenic injury.
A total of 122 patients with splenic trauma admitted to two tertiary referral centers from June 2011 to June 2014 were included in this prospective cohort study. The 67 patients at one center were treated by radiofrequency-assisted spleen-preserving therapy (RF group), and the 55 patients admitted at the other center underwent conventional treatment (CT group). Demographics and clinical characteristics of the two groups were comparable.
Compared to traditional splenorrhaphy and splenectomy, RF-assisted splenic hemostasis and salvage was safe, effective and easy to use in the treatment of splenic injuries. In particular for high-grade splenic injuries, these techniques preserved sufficient splenic tissue without any increase in patients with surgical risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RF group | Experimental | Procedure: radiofrequency ablationradiofrequency-assisted spleen-preserving therapy group. |
| CT group | No intervention | –Conventional Treatment of Blunt Splenic Injury group. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age below 70
- blunt abdominal injury combined with indication of post-traumatic splenectomy according to the guidelines provided by the Society for Surgery of the Alimentary Tract in 2005
- patients transferred directly to the trauma center after injury who had not been treated by any specific spleen-directed therapy in the transferring hospital
- AAST grade II splenic injury with hemodynamic instability or progressive bleeding requiring active intervention
- AAST grade Ⅲ-Ⅳsplenic injury, or splenic laceration involving less than 50% of the splenic parenchyma
Key exclusion criteria (5 listed)
- penetrating abdominal injury
- concomitant organ injury with an abbreviated injury scale (AIS) greater than 4 that threatened the life of the patient
- excessive vascular injury to the splenic pedicle or substantial devitalized splenic tissues when it was expected in when less than 25% of the spleen could be preserved
- patients who had failed NOM
- patients with pathologic splenic rupture
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 |
|---|---|---|
| radiofrequency ablationapply RF therapy to the treatment of splenic trauma | Procedure or surgery | RF group |
Primary outcome
Mean operative time，
Time frame: intraoperative
Mean operative time of the RF group was compared with that of CT group.
intraoperative bleeding
Time frame: intraoperative
Intraoperative bleeding of the RF group was compared with that of CT group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: No
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.
Kuansheng Ma, Ph.D principal investigator
Institute of hepatobiliary surgery,Southwest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency ablation in people with Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis, run by Southwest Hospital, China at 1 site in China.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 26 Mar 2019. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean operative time， (time frame: intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2019.