RF-assisted Splenic Preservation VS Conventional Treatmen... | NCT03890328

Studies
RF-assisted Splenic Preservation VS Conventional Treatment of Blunt Splenic Injury.

NCT03890328

Sponsor

Southwest Hospital, China

Status

Completed

Last Update Posted

Mar 26, 2019Actual

Enrollment

122Actual

Phase

Not Applicable

Conditions

Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis

Interventions

radiofrequency ablation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2009Actual

Primary Completion Date

Jun 1, 2014Actual

Completion Date

Jun 1, 2014Actual

First Submitted Date

Mar 20, 2019

First Submission Date that Met QC Criteria

Mar 24, 2019

First Posted Date

Mar 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2019

Last Update Posted Date

Mar 26, 2019Actual

Name	Class
West China Second University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RF group	Experimental	radiofrequency-assisted spleen-preserving therapy group.	Procedure: radiofrequency ablation
CT group	No Intervention	Conventional Treatment of Blunt Splenic Injury group.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiofrequency ablation	Procedure	apply RF therapy to the treatment of splenic trauma	RF group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean operative time，	Mean operative time of the RF group was compared with that of CT group.	intraoperative
intraoperative bleeding	Intraoperative bleeding of the RF group was compared with that of CT group.	intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria：

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kuansheng Ma, Ph.D	Institute of hepatobiliary surgery,Southwest Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of hepatobiliary surgery,Southwest Hospital		Chongqing	Chongqing Municipality	400038	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided