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Laparoscopic Exploration Versus Abdominal CT Scan

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ClinicalTrials.gov Identifier: NCT03923647
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Usama Amer, Assiut University

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

Condition or disease Intervention/treatment
Penetrating Abdominal Trauma Device: Laparoscopy

Detailed Description:
Evaluate the role of laparoscopy and Abdominal Ct scan in diagnosis and treatment of abdominal trauma and which is more effective and safe laparoscopy or CT

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Laparoscopic Exploration Versus Abdominal CT Scanning in Abdominal Trauma
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Laparoscopy and CT scan
Usage of laparoscopy after inflation of co2 infra umbilical
Device: Laparoscopy
Laparoscopic insertion with carbon dioxide via open technique at the umbilicus




Primary Outcome Measures :
  1. Evaluate the role of laparoscopy in diagnosis and management of abdominal trauma [ Time Frame: Baseline ]
    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

  2. Evaluate the role of Abdominal CT scanning in diagnosis of abdominal trauma [ Time Frame: Baseline ]
    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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stable patients with abdominal trauma with good general conditions
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT03923647


Contacts
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Contact: Amer +201006258917 dr.usamaamer91@gmail.com

Sponsors and Collaborators
Assiut University

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Responsible Party: Usama Amer, Usama Amer Mohammed, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03923647     History of Changes
Other Study ID Numbers: Laparoscopy in abd trauma
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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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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Abdominal Injuries
Wounds and Injuries