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

NCT04580875 | Completed

• 1 other identifier: AlAzharMIS
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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

Conditions

Penetrating Abdominal Trauma

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Rate of missed injury (number & percent)

  Rate of missed injury

  1 week

• Complications (number & percent)

  Complications

  1 year

• Mortality rate (number & percent)

  Mortality rate

  3 years

Secondary Outcomes (3)

• Operative time (in minutes)

  1 day (day of surgery)

• Hospital stay (in days)

  2 weeks

• Follow-up period (in months)

  3 years

Other Outcomes (1)

• Need for preoperative blood transfusion (number & percent)

  1 day (day of surgery)

Study Arms (2)

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.

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.

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

Interventions

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

Conservative management; Minimally invasive surgery (laparoscopy, laparoscopic-assisted procedures)

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• dr. Muhammad Abdelhafez Mahmoud, MD: lead

MeSH Terms

Interventions

Minimally Invasive Surgical Procedures; Laparoscopy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of pediatric surgery

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 9, 2020
• Study Start: January 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: February 1, 2020
• Last Updated: August 9, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: August 2020 till indefinitely
• Access Criteria: after the article became accepted and available online.