Role of Minimally Invasive Surgery in Management of Penetrating Abdominal Trauma in Children
Condition: Penetrating Abdominal Trauma
MeSH terms: Wounds and Injuries; Abdominal Injuries
Study type: Interventional

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
    

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.
    

Intervention name(s): Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Children; Penetrating Abdominal Trauma; Laparoscopy; Minimally Invasive Surgery; Urgent Laparotomy; Negative Exploration