Evaluate Laparoscopic Management in Patients With Penetrating Anterior Abdominal Wall TraumaNCT05826262
Role of Laparoscopy in Penetrating Anterior Abdominal Wall Injuries
A study testing diagnostic laparoscopy in people with Evaluate Laparoscopic Management in Patients With Penetrating Anterior Abdominal Wall Trauma, run by Sohag University at 1 site in Egypt.
Trial summary
The current study is aiming to evaluate the diagnostic and therapeutic role of laparoscopy in patients with penetrating anterior abdominal wall trauma as regard the accuracy of diagnosis and efficacy in management and avoidance of unnecessary laparotomy Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluate Laparoscopic Management in Patients With Penetrating Anterior Abdominal Wall Trauma
- What is being tested?
- diagnostic laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2023to 10 Mar 2024
- Phase
- Interventional
- 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 5 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients with penetrating anterior abdominal wall injuries Age will be between 5 - 65 years old
Who cannot join
- Vitally unstable patients Patients with associated injuries
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Ahmed omar [Ragheb], master, 01066663969 ext. 002, ahmedoragheb@gmail.com
About this study
The current study is aiming to evaluate the diagnostic and therapeutic role of laparoscopy in patients with penetrating anterior abdominal wall trauma as regard the accuracy of diagnosis and efficacy in management and avoidance of unnecessary laparotomy
- Conditions
- Evaluate Laparoscopic Management in Patients With Penetrating Anterior Abdominal Wall Trauma
- Being tested
- diagnostic laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic laparoscopyProcedure or surgery
diagnosis and management of patients with penetrating anterior abdominal wall injuries
| Study group | Role | What they receive |
|---|---|---|
| patients with penetrating anterior abdominal wall injuries | Experimental | Not described Receives: Procedure: diagnostic laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Measured: 1 month
Secondary outcomes (1)
Mortality
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start10 Mar 2023
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate Laparoscopic Management in Patients With Penetrating Anterior Abdominal Wall TraumaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Omar Ragheb, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826262
- Sponsor's protocol ID
- Soh-Med-23-03-16MS
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Laparoscopy in Penetrating Anterior Abdominal Wall Injuries
- ClinicalTrials.gov ID
- NCT05826262
- Acronym / sponsor ID
- Soh-Med-23-03-16MS
- Conditions
- Evaluate Laparoscopic Management in Patients With Penetrating Anterior Abdominal Wall Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 24 Apr 2023 (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.
The current study is aiming to evaluate the diagnostic and therapeutic role of laparoscopy in patients with penetrating anterior abdominal wall trauma as regard the accuracy of diagnosis and efficacy in management and avoidance of unnecessary laparotomy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with penetrating anterior abdominal wall injuries | Experimental | Procedure: diagnostic laparoscopy |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with penetrating anterior abdominal wall injuries Age will be between 5 - 65 years old
Key exclusion criteria (1 listed)
- Vitally unstable patients Patients with associated injuries
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 |
|---|---|---|
| diagnostic laparoscopydiagnosis and management of patients with penetrating anterior abdominal wall injuries | Procedure or surgery | patients with penetrating anterior abdominal wall injuries |
Primary outcome
Morbidity
Time frame: 1 month
1 secondary outcome
Mortality
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic laparoscopy in people with Evaluate Laparoscopic Management in Patients With Penetrating Anterior Abdominal Wall Trauma, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ahmed omar Ragheb, master (01066663969, ahmedoragheb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: 1 month). 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 24 Apr 2023.