Penetrating Abdominal TraumaNCT03923647
Laparoscopic Exploration Versus Abdominal CT Scan
An observational study of Penetrating Abdominal Trauma, run by Assiut University.
Trial summary
Evaluate the efficacy and safety of laparoscopy and it's role with blunt abdominal trauma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Penetrating Abdominal Trauma
- What is being tested?
- Laparoscopy
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable patients with abdominal trauma with good general conditions
Who may be able to join
- stable patients with definite occurrence of intra-abdominal injury
- patients with equivocal result by clinical and radiological evaluation
Who cannot join
- patients with penetrating abdominal trauma
- stable patients not in need for any intervention for conservative management
- patients with marked haemodynamic instability
- polyt-traumatized Patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Laparoscopic Exploration Versus Abdominal CT Scanning in Abdominal Trauma
Evaluate the efficacy and safety of laparoscopy and it's role with blunt abdominal trauma
Read the 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
- Conditions
- Penetrating Abdominal Trauma
- Being tested
- Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyDevice
Laparoscopic insertion with carbon dioxide via open technique at the umbilicus
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy and CT scan | Usage of laparoscopy after inflation of co2 infra umbilical Receives: Device: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Sep 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penetrating Abdominal TraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usama Amer, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923647
- Sponsor's protocol ID
- Laparoscopy in abd trauma
- Status last verified
- Jul 2019
- First submitted
- 6 Apr 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Exploration Versus Abdominal CT Scanning in Abdominal Trauma
- ClinicalTrials.gov ID
- NCT03923647
- Acronym / sponsor ID
- Laparoscopy in abd trauma
- Conditions
- Penetrating Abdominal Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of laparoscopy and it's role with blunt abdominal trauma
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy and CT scan | – | Device: LaparoscopyUsage of laparoscopy after inflation of co2 infra umbilical |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable patients with abdominal trauma with good general conditions
Key inclusion criteria (2 listed)
- stable patients with definite occurrence of intra-abdominal injury
- patients with equivocal result by clinical and radiological evaluation
Key exclusion criteria (4 listed)
- patients with penetrating abdominal trauma
- stable patients not in need for any intervention for conservative management
- patients with marked haemodynamic instability
- polyt-traumatized Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaparoscopyLaparoscopic insertion with carbon dioxide via open technique at the umbilicus | Device | Laparoscopy and CT scan |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Penetrating Abdominal Trauma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amer (+201006258917, dr.usamaamer91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the role of laparoscopy in diagnosis and management of abdominal trauma (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.