Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04580875 |
| Other study ID # |
AlAzharMIS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2015 |
| Est. completion date |
February 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Al-Azhar University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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
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.
