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Role of Minimally Invasive Surgery in Management of Penetrating Abdominal Trauma in Children (MISinPAT)

Primary Purpose

Penetrating Abdominal Trauma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children
Sponsored by
dr. Muhammad Abdelhafez Mahmoud, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Penetrating Abdominal Trauma focused on measuring Children, Penetrating Abdominal Trauma, Laparoscopy, Minimally Invasive Surgery, Urgent Laparotomy, Negative Exploration

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children up to 14 years of age with penetrating trauma having the potential to violate the peritoneum,
  • Hemodynamically stable, or
  • Responded to initial resuscitation

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Minimally invasive surgery (laparoscopy, laparoscopic-assisted procedures)

    Conservative management

    Arm Description

    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.

    patients aged from 1-14 years presenting to the ER by penetrating abdominal trauma with imsignificant findings will be managed conservatively.

    Outcomes

    Primary Outcome Measures

    Rate of missed injury (number & percent)
    Rate of missed injury
    Complications (number & percent)
    Complications
    Mortality rate (number & percent)
    Mortality rate

    Secondary Outcome Measures

    Operative time (in minutes)
    Operative time
    Hospital stay (in days)
    postoperative hospital stay
    Follow-up period (in months)
    Follow-up period

    Full Information

    First Posted
    September 29, 2020
    Last Updated
    August 2, 2021
    Sponsor
    dr. Muhammad Abdelhafez Mahmoud, MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04580875
    Brief Title
    Role of Minimally Invasive Surgery in Management of Penetrating Abdominal Trauma in Children
    Acronym
    MISinPAT
    Official Title
    Role of Minimally Invasive Surgery in Management of Penetrating Abdominal Trauma in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    July 2019 (Actual)
    Study Completion Date
    February 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    dr. Muhammad Abdelhafez Mahmoud, MD

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Penetrating Abdominal Trauma
    Keywords
    Children, Penetrating Abdominal Trauma, Laparoscopy, Minimally Invasive Surgery, Urgent Laparotomy, Negative Exploration

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    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
    InvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Minimally invasive surgery (laparoscopy, laparoscopic-assisted procedures)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Conservative management
    Arm Type
    Active Comparator
    Arm Description
    patients aged from 1-14 years presenting to the ER by penetrating abdominal trauma with imsignificant findings will be managed conservatively.
    Intervention Type
    Procedure
    Intervention Name(s)
    Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children
    Primary Outcome Measure Information:
    Title
    Rate of missed injury (number & percent)
    Description
    Rate of missed injury
    Time Frame
    1 week
    Title
    Complications (number & percent)
    Description
    Complications
    Time Frame
    1 year
    Title
    Mortality rate (number & percent)
    Description
    Mortality rate
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Operative time (in minutes)
    Description
    Operative time
    Time Frame
    1 day (day of surgery)
    Title
    Hospital stay (in days)
    Description
    postoperative hospital stay
    Time Frame
    2 weeks
    Title
    Follow-up period (in months)
    Description
    Follow-up period
    Time Frame
    3 years
    Other Pre-specified Outcome Measures:
    Title
    Need for preoperative blood transfusion (number & percent)
    Description
    Need for preoperative blood transfusion
    Time Frame
    1 day (day of surgery)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children up to 14 years of age with penetrating trauma having the potential to violate the peritoneum, Hemodynamically stable, or Responded to initial resuscitation Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data are available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study add to the literature
    IPD Sharing Time Frame
    August 2020 till indefinitely
    IPD Sharing Access Criteria
    after the article became accepted and available online.

    Learn more about this trial

    Role of Minimally Invasive Surgery in Management of Penetrating Abdominal Trauma in Children

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