Laparoscopic Exploration Versus Abdominal CT Scan

Laparoscopic Exploration Versus Abdominal CT Scanning in Abdominal Trauma

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

Study Overview

• Status: Unknown
• Conditions: Penetrating Abdominal Trauma
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stable patients with abdominal trauma with good general conditions

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: April 6, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (ACTUAL): April 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Abdominal Injuries
• Other Study ID Numbers: Laparoscopy in abd trauma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No