Penetrating Abdominal TraumaMISinPATNCT04580875
Role of Minimally Invasive Surgery in Management of Penetrating Abdominal Trauma in Children
A study testing Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children in people with Penetrating Abdominal Trauma, run by dr. Muhammad Abdelhafez Mahmoud, MD.
Trial summary
Exploratory laparotomy has been traditionally used for managing penetrating abdominal trauma (PAT). Currently, minimally invasive surgery (for diagnosis and treatment purposes) is a well-established and rapidly growing modality for dealing with penetrating abdominal trauma in stable children. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Penetrating Abdominal Trauma
- What is being tested?
- Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2020
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children up to 14 years of age with penetrating trauma having the potential to violate the peritoneum,
- Hemodynamically stable, or
- Responded to initial resuscitation
Who cannot join
- Patients with blunt trauma,
- Penetrating trauma cases non-responding to initial resuscitation thus mandating urgent, laparotomy,
- Peritonitis,
- Sepsis,
- Patients older than 14 years,
- Cases requiring damage-control strategy.
About this study
Exploratory laparotomy has been traditionally used for managing penetrating abdominal trauma (PAT). Currently, minimally invasive surgery (for diagnosis and treatment purposes) is a well-established and rapidly growing modality for dealing with penetrating abdominal trauma in stable children. Herein, we aimed to evaluate the effectiveness and outcomes and emphasize the importance of timely intervention by minimally invasive surgery for PAT possessing the potential to violate the peritoneum in stable pediatric victims.
This prospective study was carried out on 102 hemodynamically stable pediatric cases with highly suspicious penetrating abdominal trauma (caused by gunshot, stab, \& accidental stab), admitted and managed by minimally invasive surgery (laparoscopy \& laparoscopic-assisted procedures). Information recorded for analysis included demographic data, anatomical location of injury, organs affected, operative findings, operative time, need for conversion to laparoscopic-assisted approach, length of stay, complications, missed injury, and mortality rate.
Read more
A total of 102 pediatric cases with highly suspicious penetrating abdominal trauma (PAT) were managed by minimally invasive surgery (MIS). They were 62 males and 40 females with mean age of 7.3±0.6 years (range, 1-14 years). They included 39 cases of gunshot, 30 cases of stab abdomen, and 33 cases of accidental stab.
In this study, there was 100% accuracy in defining the injured organs with zero percent missed injuries in addition to effective therapeutic potential as regard the role of minimally invasive surgery in management of penetrating abdominal trauma in children.
Type of Study: Prospective cohort study
Read the detailed description
Aim of the study:
Herein, the investigators aim to present our experience, evaluate the effectiveness \& outcomes, and emphasize the importance of timely intervention by minimally invasive surgery in managing PAT highly suspicious to violate the peritoneum in hemodynamically stable children.
Review of literature:
- Different management modalities of penetrating abdominal trauma in children (conservative, routine exploratory laparotomy, Laparoscopy).
- Disadvantages of selective non-operative management (SNOM) and negative (non-therapeutic) laparotomy for penetrating abdominal trauma in children.
- Merits of diagnostic and therapeutic laparoscopy for penetrating abdominal trauma in children.
Patients and Methods:
This is a prospective study, will be conducted out at 3 pediatric surgery tertiary centers (Al-Azhar University hospitals in Cairo, Prince Mohammed bin Abdul-Aziz Hospital in Riyadh and Maternity \& Children's Hospital in KSA) on pediatric patients presenting to the ER by penetrating abdominal trauma in the period from January 2015 to February 2021. Responders to initial resuscitation will be managed by minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures). The total anatomical region of interest is defined as the cylindrical area bounded superiorly by the nipple line and the inferiorly by symphysis pubis. All patients enrolled in the study will give a written informed consent even for possible conversion to laparotomy if necessary. The study will be approved by the Institutional Review Board and ethics committee of the hospitals. All bullets and sharp objects will be removed during the procedures after optimum secure hemostasis. The main objective is to laparoscopically manage all PAT highly suspicious to violate the peritoneum.
Cases will be admitted, resuscitated, and stabilized as per pediatric advanced life support (PALS) and advanced trauma life support (ATLS) protocol guidelines, meanwhile, cases will be investigated by appropriate laboratory \& radiologic studies. All patients will undergo E-FAST ultrasound and contrast abdominopelvic CT. Documented patients' data will include patient demographics, mechanism of injury, location of injury, pediatric trauma score (PTS) on admission (included weight, systolic blood pressure, mental status, airway condition, skeletal fracture, \& open wounds), need for preoperative blood transfusion, surgical approach, operative findings, duration of hospital stay, complications, need for re-intervention, and follow-up period.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals in Cairo, Prince Mohammed bin Abdul-Aziz hospital (PMAH) in Riyadh, and Maternity \& Children's hospital in KSA.
Number of cases: One-hundred-Two cases. Time frame: period of 5 years.
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee at PMAH and other participating hospitals. The procedures and the aim of the study will be clearly explained to the patient and the family. A written informed consent will be obtained before enrollment of the patients into the study. The family refusal to give consent for laparoscopic management is respected but does not deprive the patient from getting surgical care by exploration laparotomy.
Preoperative preparation:
All patients will be subjected to full clinical examination, rapid history taking, and necessary laboratory investigations (CBC, Coagulation profile, Liver and Renal Function tests, rapid serology for HBV, HCV, \& HIV) and preoperative imaging (E-FAST, CT). They will be rapidly assessed and resuscitated. They will receive a dose of triple broad-spectrum antibiotics 30 min-1 hour before surgery.
Follow-up:
Patients were followed-up for median period of 52±17.12 months (range, 6-60 months) with no patients lost to follow-up. Ninety-two patients were reviewed at the office clinic and 10 patients were contacted by phone.
Statistical analysis:
Data were analyzed using the statistical package for social sciences (SPSS) version 24.0 (IBM Corp, IBM SPSS Statistics for Windows, Armonk, NY, USA). Continuous variables were expressed as mean± standard deviation (SD), range, and average while categorical variables were expressed as frequency count and percentage. Fisher's exact test was used for comparison of frequency counts/percentage. The t test was used for comparison of mean values. A two-sided p value less than 0.05 was considered statistically significant.
Discussion:
Discussion will focus on laparoscopic management of penetrating abdominal trauma in children. The results obtained from this study will be compared with each other and with that reported in the literature.
The discussion will focus on operative difficulties, operative time, conversion to directed laparotomy (laparoscopic-assisted procedure), and complications. It will compare results of this study with the results of others. Discussion will determine the most accurate management modality for penetrating abdominal trauma in children which offers the best outcome and least morbidity.
- Conditions
- Penetrating Abdominal Trauma
- Being tested
- Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children
- Keywords
- Children, Penetrating Abdominal Trauma, Laparoscopy, Minimally Invasive Surgery, Urgent Laparotomy, Negative Exploration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in ChildrenProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive surgery (laparoscopy, laparoscopic-assisted procedures) | Active comparator | This study will be conducted out at 3 pediatric surgery tertiary centers (Al-Azhar University hospitals in Cairo, Prince Mohammed bin Abdulaziz Hospital in Riyadh and Maternity \& Children's Hospital in Bisha) on patients aged from 1-14 years presenting to the ER by stable penetrating abdominal trauma with significant clinical/radiologic findings, in the period from April 2017 to March 2022. Responders to initial resuscitation will be managed by minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures). All patients enrolled in the study will give a written informed consent even for possible conversion to laparotomy if necessary. Receives: Procedure: Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children |
| Conservative management | Active comparator | patients aged from 1-14 years presenting to the ER by penetrating abdominal trauma with imsignificant findings will be managed conservatively. Receives: Procedure: Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of missed injury (number & percent)
Rate of missed injury
Measured: 1 week
Complications (number & percent)
Complications
Measured: 1 year
Mortality rate (number & percent)
Mortality rate
Measured: 3 years
Secondary outcomes (3)
Operative time (in minutes)
Operative time
Measured: 1 day (day of surgery)
Hospital stay (in days)
postoperative hospital stay
Measured: 2 weeks
Follow-up period (in months)
Follow-up period
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study startJan 2015
- Primary completionJul 2019
- Study completionFeb 2020
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.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective cohort study. within the same facility, cases were enrolled consecutively but at some instances, in 2 or the 3 facilities at the same time, a portion of cases were managed simultaneously.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. Muhammad Abdelhafez Mahmoud, MD, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580875
- Sponsor's protocol ID
- AlAzharMIS
- Acronym
- MISinPAT
- Status last verified
- Oct 2020
- First submitted
- 29 Sep 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study add to the literature
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Minimally Invasive Surgery in Management of Penetrating Abdominal Trauma in Children
- ClinicalTrials.gov ID
- NCT04580875
- Acronym / sponsor ID
- MISinPAT / AlAzharMIS
- Conditions
- Penetrating Abdominal Trauma
- Keywords
- Children, Penetrating Abdominal Trauma, Laparoscopy, Minimally Invasive Surgery, Urgent Laparotomy, Negative Exploration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MDUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 9 Oct 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.
Exploratory laparotomy has been traditionally used for managing penetrating abdominal trauma (PAT). Currently, minimally invasive surgery (for diagnosis and treatment purposes) is a well-established and rapidly growing modality for dealing with penetrating abdominal trauma in stable children. Herein, we aimed to evaluate the effectiveness and outcomes and emphasize the importance of timely intervention by minimally invasive surgery for PAT possessing the potential to violate the peritoneum in stable pediatric victims.
This prospective study was carried out on 102 hemodynamically stable pediatric cases with highly suspicious penetrating abdominal trauma (caused by gunshot, stab, \& accidental stab), admitted and managed by minimally invasive surgery (laparoscopy \& laparoscopic-assisted procedures). Information recorded for analysis included demographic data, anatomical location of injury, organs affected, operative findings, operative time, need for conversion to laparoscopic-assisted approach, length of stay, complications, missed injury, and mortality rate.
A total of 102 pediatric cases with highly suspicious penetrating abdominal trauma (PAT) were managed by minimally invasive surgery (MIS). They were 62 males and 40 females with mean age of 7.3±0.6 years (range, 1-14 years). They included 39 cases of gunshot, 30 cases of stab abdomen, and 33 cases of accidental stab.
In this study, there was 100% accuracy in defining the injured organs with zero percent missed injuries in addition to effective therapeutic potential as regard the role of minimally invasive surgery in management of penetrating abdominal trauma in children.
Type of Study: Prospective cohort study
Detailed description
Aim of the study:
Herein, the investigators aim to present our experience, evaluate the effectiveness \& outcomes, and emphasize the importance of timely intervention by minimally invasive surgery in managing PAT highly suspicious to violate the peritoneum in hemodynamically stable children.
Review of literature:
- Different management modalities of penetrating abdominal trauma in children (conservative, routine exploratory laparotomy, Laparoscopy).
- Disadvantages of selective non-operative management (SNOM) and negative (non-therapeutic) laparotomy for penetrating abdominal trauma in children.
- Merits of diagnostic and therapeutic laparoscopy for penetrating abdominal trauma in children.
Patients and Methods:
This is a prospective study, will be conducted out at 3 pediatric surgery tertiary centers (Al-Azhar University hospitals in Cairo, Prince Mohammed bin Abdul-Aziz Hospital in Riyadh and Maternity \& Children's Hospital in KSA) on pediatric patients presenting to the ER by penetrating abdominal trauma in the period from January 2015 to February 2021. Responders to initial resuscitation will be managed by minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures). The total anatomical region of interest is defined as the cylindrical area bounded superiorly by the nipple line and the inferiorly by symphysis pubis. All patients enrolled in the study will give a written informed consent even for possible conversion to laparotomy if necessary. The study will be approved by the Institutional Review Board and ethics committee of the hospitals. All bullets and sharp objects will be removed during the procedures after optimum secure hemostasis. The main objective is to laparoscopically manage all PAT highly suspicious to violate the peritoneum.
Cases will be admitted, resuscitated, and stabilized as per pediatric advanced life support (PALS) and advanced trauma life support (ATLS) protocol guidelines, meanwhile, cases will be investigated by appropriate laboratory \& radiologic studies. All patients will undergo E-FAST ultrasound and contrast abdominopelvic CT. Documented patients' data will include patient demographics, mechanism of injury, location of injury, pediatric trauma score (PTS) on admission (included weight, systolic blood pressure, mental status, airway condition, skeletal fracture, \& open wounds), need for preoperative blood transfusion, surgical approach, operative findings, duration of hospital stay, complications, need for re-intervention, and follow-up period.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals in Cairo, Prince Mohammed bin Abdul-Aziz hospital (PMAH) in Riyadh, and Maternity \& Children's hospital in KSA.
Number of cases: One-hundred-Two cases. Time frame: period of 5 years.
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee at PMAH and other participating hospitals. The procedures and the aim of the study will be clearly explained to the patient and the family. A written informed consent will be obtained before enrollment of the patients into the study. The family refusal to give consent for laparoscopic management is respected but does not deprive the patient from getting surgical care by exploration laparotomy.
Preoperative preparation:
All patients will be subjected to full clinical examination, rapid history taking, and necessary laboratory investigations (CBC, Coagulation profile, Liver and Renal Function tests, rapid serology for HBV, HCV, \& HIV) and preoperative imaging (E-FAST, CT). They will be rapidly assessed and resuscitated. They will receive a dose of triple broad-spectrum antibiotics 30 min-1 hour before surgery.
Follow-up:
Patients were followed-up for median period of 52±17.12 months (range, 6-60 months) with no patients lost to follow-up. Ninety-two patients were reviewed at the office clinic and 10 patients were contacted by phone.
Statistical analysis:
Data were analyzed using the statistical package for social sciences (SPSS) version 24.0 (IBM Corp, IBM SPSS Statistics for Windows, Armonk, NY, USA). Continuous variables were expressed as mean± standard deviation (SD), range, and average while categorical variables were expressed as frequency count and percentage. Fisher's exact test was used for comparison of frequency counts/percentage. The t test was used for comparison of mean values. A two-sided p value less than 0.05 was considered statistically significant.
Discussion:
Discussion will focus on laparoscopic management of penetrating abdominal trauma in children. The results obtained from this study will be compared with each other and with that reported in the literature.
The discussion will focus on operative difficulties, operative time, conversion to directed laparotomy (laparoscopic-assisted procedure), and complications. It will compare results of this study with the results of others. Discussion will determine the most accurate management modality for penetrating abdominal trauma in children which offers the best outcome and least morbidity.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective cohort study. within the same facility, cases were enrolled consecutively but at some instances, in 2 or the 3 facilities at the same time, a portion of cases were managed simultaneously.
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive surgery (laparoscopy, laparoscopic-assisted procedures) | Active comparator | Procedure: Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in ChildrenThis study will be conducted out at 3 pediatric surgery tertiary centers (Al-Azhar University hospitals in Cairo, Prince Mohammed bin Abdulaziz Hospital in Riyadh and Maternity \& Children's Hospital in Bisha) on patients aged from 1-14 years presenting to the ER by stable penetrating abdominal trauma with significant clinical/radiologic findings, in the period from April 2017 to March 2022. Responders to initial resuscitation will be managed by minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures). All patients enrolled in the study will give a written informed consent even for possible conversion to laparotomy if necessary. |
| Conservative management | Active comparator | Procedure: Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Childrenpatients aged from 1-14 years presenting to the ER by penetrating abdominal trauma with imsignificant findings will be managed conservatively. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children up to 14 years of age with penetrating trauma having the potential to violate the peritoneum,
- Hemodynamically stable, or
- Responded to initial resuscitation
Key exclusion criteria (6 listed)
- Patients with blunt trauma,
- Penetrating trauma cases non-responding to initial resuscitation thus mandating urgent, laparotomy,
- Peritonitis,
- Sepsis,
- Patients older than 14 years,
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 |
|---|---|---|
| Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children | Procedure or surgery | Conservative management, Minimally invasive surgery (laparoscopy, laparoscopic-assisted procedures) |
Primary outcome
Rate of missed injury (number & percent)
Time frame: 1 week
Rate of missed injury
Complications (number & percent)
Time frame: 1 year
Complications
Mortality rate (number & percent)
Time frame: 3 years
Mortality rate
3 secondary outcomes
Operative time (in minutes)
Time frame: 1 day (day of surgery)
Hospital stay (in days)
Time frame: 2 weeks
Follow-up period (in months)
Time frame: 3 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 9 Aug 2021.
- Individual participant dataSharing planned: Yes. Data are available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study add to the literature
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children in people with Penetrating Abdominal Trauma, run by dr. Muhammad Abdelhafez Mahmoud, MD.
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 3 inclusion and 6 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 9 Aug 2021. 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?
Rate of missed injury (number & percent) (time frame: 1 week). The study lists 3 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 9 Aug 2021.