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Traumatic Injury of Spleen:Laparoscopic Splenectomy Vs Splenic Artery Embolization

Z

Zagazig University

Status

Active, not recruiting

Conditions

Grade III Traumatic Splenic Injury in Hemodynamically Stable Patients

Treatments

Procedure: Laparoscopic Splenectomy vs splenic Artery Embolization

Study type

Interventional

Funder types

Other

Identifiers

NCT07274007
ZU-IRB# 775/17-Nov-2024

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Laparoscopic Splenectomy
Active Comparator group
Treatment:
Procedure: Laparoscopic Splenectomy vs splenic Artery Embolization
Splenic Artery Embolization
Active Comparator group
Treatment:
Procedure: Laparoscopic Splenectomy vs splenic Artery Embolization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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