NCT04572204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

September 27, 2020

Last Update Submit

February 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stabilization of haemodynamic status of the patient in the first 24-72 hours

    24 to 72 hours

Secondary Outcomes (1)

  • Resolution of perinephric collection during follow up Triphasic MSCT abdomen and pelvis

    1 year

Study Arms (2)

Conservative group

interventional group

Other: Surgical

Interventions

Minimal: Such as PCN insertion Endosopic: Such as DJ insertion Surgical: Repair, Partial or total nephrectomy Angioembolization

interventional group

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

60 children (age group 0-18 years) will be added to my study divided into two groups regardless of sex

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71717, Egypt

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 27, 2020

First Posted

October 1, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2022

Study Completion

October 30, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations