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Management of Grades 3-5 Renal Trauma in Pediatrics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04572204
Recruitment Status : Active, not recruiting
First Posted : October 1, 2020
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Ahmed Hamdan Gameel, Assiut University

Study Description
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Brief Summary:
comparing conservative management versus interventional management in hemodynamically stable paediatric patient with blunt renal trauma, evidence suggests that there is a reduced rate of renal loss and blood transfusion in patients managed conservatively.

Condition or disease Intervention/treatment
Renal Trauma Other: Surgical

Study Design
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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Grades 3-5 Renal Trauma in Pediatrics: A Prospective Case Series
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : October 30, 2022

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Conservative group
interventional group Other: Surgical
Minimal: Such as PCN insertion Endosopic: Such as DJ insertion Surgical: Repair, Partial or total nephrectomy Angioembolization


Outcome Measures
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Primary Outcome Measures :
  1. Stabilization of haemodynamic status of the patient in the first 24-72 hours [ Time Frame: 24 to 72 hours ]

Secondary Outcome Measures :
  1. Resolution of perinephric collection during follow up Triphasic MSCT abdomen and pelvis [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
60 children (age group 0-18 years) will be added to my study divided into two groups regardless of sex
Criteria

Inclusion Criteria:

  • Children ( age group 0-18) who are diagnosed to have renal tissue injury grade 3-5 by contrast CT

Exclusion Criteria:

  • Age group more than 18 years
  • Low grade renal trauma 1-2
  • Patients who get explored due to extra urologic indication without proper urologic assessment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572204


Locations
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Egypt
Assiut University
Assiut, Egypt, 71717
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Ahmed Hamdan Gameel, Resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04572204    
Other Study ID Numbers: Renal trauma management
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries