NCT03923647

Brief Summary

Evaluate the efficacy and safety of laparoscopy and it's role with blunt abdominal trauma

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Status
unknown

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

April 6, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

April 6, 2019

Last Update Submit

July 2, 2019

Conditions

Penetrating Abdominal Trauma

Outcome Measures

Primary Outcomes (2)

  • Evaluate the role of laparoscopy in diagnosis and management of abdominal trauma

    Evaluate the efficacy and safety of laparoscopy in diagnosis of abdominal trauma in comparison to abdominal CT scanning in 30 stable patients with with abdominal trauma

    Baseline

  • Evaluate the role of Abdominal CT scanning in diagnosis of abdominal trauma

    Evaluate the accuracy of CT scanning in diagnosis of abdominal trauma according to 1- age of the patient 2- amount of dye 3- general conditions of the patient 4- history of medical disease

    Baseline

Study Arms (1)

Laparoscopy and CT scan

Usage of laparoscopy after inflation of co2 infra umbilical

Device: Laparoscopy

Interventions

LaparoscopyDEVICE

Laparoscopic insertion with carbon dioxide via open technique at the umbilicus

Laparoscopy and CT scan

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stable patients with abdominal trauma with good general conditions

You may qualify if:

  • stable patients with definite occurrence of intra-abdominal injury
  • patients with equivocal result by clinical and radiological evaluation

You may not qualify if:

  • patients with penetrating abdominal trauma
  • stable patients not in need for any intervention for conservative management
  • patients with marked haemodynamic instability
  • polyt-traumatized Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Amer

CONTACT

+201006258917dr.usamaamer91@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Usama Amer Mohammed, principal investigator

Study Record Dates

First Submitted

April 6, 2019

First Posted

April 22, 2019

Study Start

September 1, 2019

Primary Completion

April 1, 2020

Study Completion

October 1, 2020

Last Updated

July 5, 2019

Record last verified: 2019-07