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Clinical Trials/NCT07274007
NCT07274007Active, not recruitingNot Applicable

Management of Grade III Traumatic Splenic Injury in Hemodynamically Stable Patients ; Laparoscopic Splenectomy Versus Splenic Artery Embolization by Interventional Radiology

Zagazig University1 site in 1 country24 target enrollmentStarted: December 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
24
Locations
1
Primary Endpoint
Number of participants with clinical complications: as pain, fever, leucocytosis, vomiting, or illeus.

Study Overview

Brief Summary

The goal of this clinical trial is selection of the best method in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients thus improving the quality of life and clinical outcome. The main questions it aims to answer are

  1. Assess the quality of life and clinical outcome after using laparoscopic Splenectomy in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients
  2. Assess the quality of life and clinical outcome after using Splenic Artery Embolization in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients

Researchers will compare the quality of life and clinical outcome to see if it is better using laparoscopic Splenectomy Splenic Artery Embolization

Participants will underwent laparoscopic Splenectomy or Splenic Artery Embolization and will undwent post operative follow up, follow up at outpatient clinic and will be asked about changes occurring to their daily life social activities and their quality of life

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients aged above 12 years at time of screening.
  • Patients diagnosed with grade three traumatic Splenic Injury

Exclusion Criteria

  • Patients aged less than 12 years at time of screening .
  • Patients diagnosed with associated visceral injury such as "liver,kidney,bowel, etc..".
  • Patients diagnosed with isolated splenic injury after trauma other than grades III
  • Patients contraindicated for radiological investigations or splenic artery embolization using interventional radiology such as pregnany

Outcomes

Primary Outcomes

Number of participants with clinical complications: as pain, fever, leucocytosis, vomiting, or illeus.

Time Frame: 6 months

Number of participants with clinical complications: like Pain, fever, leucocytosis, vomiting, or illeus.

Secondary Outcomes

  • Recovery time: Length of postoperative hospital stay in days.(6 months.)
  • Measuring post operative pain severity using pain severity score.(6 months.)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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