Laparoscopic SurgeryNCT04329845
Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries
A study testing open splenectomy and laparoscopic splenectomy for splenic injury in trauma in people with Laparoscopic Surgery, run by Zagazig University.
Trial summary
Background: Trauma laparoscopic splenectomy has no defined reasons. Compared trauma patient characteristics and results with laparoscopic and open splenectomies. Methods: Patients aged 15 or older with blunt splenic injuries from January 2012 to July 2017 needed splenectomy. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- open splenectomy and laparoscopic splenectomy for splenic injury in trauma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jan 2019
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- • At least 15 years old.
- Male and female (not pregnant) patients; • Sonar and CT scans before surgery showed single splenic damage;
Who cannot join
- • Other damage to the abdomen, thorax, or nerves were found before surgery.
- good use of non-surgical treatment or embolization
- Woman who is pregnant.
- Splenic cuts that go deep.
- Previous surgery in the upper abdomen using a laparoscopic method. • Other injuries to the abdomen found during surgery, such as liver, intestine, or bladder injuries.
About this study
Official title: Myth and Facts About the Evolving Role of Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries in Hemodynamically Stable Patients With Blunt Abdominal Trauma .Randomized Controlled Trials
Background: Trauma laparoscopic splenectomy has no defined reasons. Compared trauma patient characteristics and results with laparoscopic and open splenectomies.
Methods: Patients aged 15 or older with blunt splenic injuries from January 2012 to July 2017 needed splenectomy. Demographics, splenic damage grade, approach (open or laparoscopic), surgery duration, intra-operative blood loss, transfusions, hospital stay, complications, and death were variables.
Read the detailed description
The spleen might be injured in left lower chest or upper abdomen trauma. Rib cage, diaphragm, pancreas, and bowel injuries may occur with splenic injuries. Hemodynamic instability, a rising heart rate, and low blood pressure are symptoms of damage, however the mechanism of injury requires a high index of suspicion.
- Conditions
- Laparoscopic Surgery
- Being tested
- open splenectomy, laparoscopic splenectomy for splenic injury in trauma
- Keywords
- laparoscopy, laparotomy, non-penetrating, splenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open splenectomyProcedure or surgery
open splenectomy for treatment of splenic injury
laparoscopic splenectomy for splenic injury in traumaProcedure or surgery
laparoscopy as a technique for removal of the spleen in injury
| Study group | Role | What they receive |
|---|---|---|
| open splenectomy for splenic injury in trauma | Active comparator | open splenectomy as a technique for removal of the spleen in case of injury to spleen Receives: Procedure: open splenectomy |
| laparoscopic splenectomy for splenic injury in trauma | Active comparator | laparoscopic splenectomy as a technique for removal of the spleen in case of injury to spleen Receives: Procedure: laparoscopic splenectomy for splenic injury in trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
during operation or immediate postoperative
Measured: 1.5 years
Secondary outcomes (1)
intraoperative complications
intraoperative complications
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Jan 2012
- Primary completion1 Jul 2017
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
- Investigators
- tamer A. alnaimy, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329845
- Sponsor's protocol ID
- zagazig 6
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2020
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myth and Facts About the Evolving Role of Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries in Hemodynamically Stable Patients With Blunt Abdominal Trauma .Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT04329845
- Acronym / sponsor ID
- zagazig 6
- Conditions
- Laparoscopic Surgery
- Keywords
- laparoscopy, laparotomy, non-penetrating, splenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 1 Apr 2020 (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.
Background: Trauma laparoscopic splenectomy has no defined reasons. Compared trauma patient characteristics and results with laparoscopic and open splenectomies.
Methods: Patients aged 15 or older with blunt splenic injuries from January 2012 to July 2017 needed splenectomy. Demographics, splenic damage grade, approach (open or laparoscopic), surgery duration, intra-operative blood loss, transfusions, hospital stay, complications, and death were variables.
Detailed description
The spleen might be injured in left lower chest or upper abdomen trauma. Rib cage, diaphragm, pancreas, and bowel injuries may occur with splenic injuries. Hemodynamic instability, a rising heart rate, and low blood pressure are symptoms of damage, however the mechanism of injury requires a high index of suspicion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open splenectomy for splenic injury in trauma | Active comparator | Procedure: open splenectomyopen splenectomy as a technique for removal of the spleen in case of injury to spleen |
| laparoscopic splenectomy for splenic injury in trauma | Active comparator | Procedure: laparoscopic splenectomy for splenic injury in traumalaparoscopic splenectomy as a technique for removal of the spleen in case of injury to spleen |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- • At least 15 years old.
Key exclusion criteria (5 listed)
- • Other damage to the abdomen, thorax, or nerves were found before surgery.
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 |
|---|---|---|
| open splenectomyopen splenectomy for treatment of splenic injury | Procedure or surgery | open splenectomy for splenic injury in trauma |
| laparoscopic splenectomy for splenic injury in traumalaparoscopy as a technique for removal of the spleen in injury | Procedure or surgery | laparoscopic splenectomy for splenic injury in trauma |
Primary outcome
mortality
Time frame: 1.5 years
during operation or immediate postoperative
1 secondary outcome
intraoperative complications
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Laparoscopic Surgery
Not yet recruitingObservational study
Fluid Responsiveness in Laparoscopic Surgery: End-Expiratory Occlusion Test Versus Mini-Fluid Challenge
Fluid Responsiveness, Laparoscopic Surgery
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Not yet recruiting
Generative AI-Assisted Personalized Feedback for Laparoscopic Skill Learning in Medical Undergraduates
Medical Education
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
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.
tamer A. alnaimy, MD principal investigator
Zagazig University
Questions about this trial
What is this clinical trial studying?
A study testing open splenectomy and laparoscopic splenectomy for splenic injury in trauma in people with Laparoscopic Surgery, run by Zagazig 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 5 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: finished, as of the sponsor's last update on 28 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 1.5 years). 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 28 Mar 2024.