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CompletedNCT04580875MISinPATUpdated Aug 9, 2021

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

An interventional study of Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children in Penetrating Abdominal Trauma, sponsored by dr. Muhammad Abdelhafez Mahmoud, MD. Completed. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2021-08-09.

Sponsored by dr. Muhammad Abdelhafez Mahmoud, MD · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Non-randomized
Ages
1 Year to 14 Years
Sex
All
01

Study 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

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.

02

Conditions studied

  • Penetrating Abdominal Trauma

Keywords

  • Children
  • Penetrating Abdominal Trauma
  • Laparoscopy
  • Minimally Invasive Surgery
  • Urgent Laparotomy
  • Negative Exploration
03

Who can participate

Ages eligible
1 Year to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • Active comparator
    Minimally invasive surgery (laparoscopy, laparoscopic-assisted procedures)

    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.

    Procedure: Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children

  • Active comparator
    Conservative management

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

    Procedure: Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children

Interventions

  • ProcedureMinimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children
05

What researchers measure

Primary outcomes

  1. Rate of missed injury (number & percent)

    Rate of missed injury

    Time frame: 1 week

  2. Complications (number & percent)

    Complications

    Time frame: 1 year

  3. Mortality rate (number & percent)

    Mortality rate

    Time frame: 3 years

Secondary outcomes

  1. Operative time (in minutes)

    Operative time

    Time frame: 1 day (day of surgery)

  2. Hospital stay (in days)

    postoperative hospital stay

    Time frame: 2 weeks

  3. Follow-up period (in months)

    Follow-up period

    Time frame: 3 years

Other outcomes

  1. Need for preoperative blood transfusion (number & percent)

    Need for preoperative blood transfusion

    Time frame: 1 day (day of surgery)

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04580875
Lead sponsor
dr. Muhammad Abdelhafez Mahmoud, MD
Responsible party
dr. Muhammad Abdelhafez Mahmoud, MD (Lecturer of pediatric surgery, Al-Azhar University) — Sponsor-investigator
First posted
Oct 9, 2020
Start date
Jan 2015
Primary completion
Jul 2019
Completion
Feb 2020
Last update
Aug 9, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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