Role of Minimally Invasive Surgery in Management of Penetrating Abdominal Trauma in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 主要终点
- Rate of missed injury (number & percent)
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children up to 14 years of age with penetrating trauma having the potential to violate the peritoneum,
- •Hemodynamically stable, or
- •Responded to initial resuscitation
排除标准
- •Patients with blunt trauma,
- •Penetrating trauma cases non-responding to initial resuscitation thus mandating urgent, laparotomy,
- •Peritonitis,
- •Patients older than 14 years,
- •Cases requiring damage-control strategy.
研究组 & 干预措施
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.
干预措施: Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children (Procedure)
Conservative management
patients aged from 1-14 years presenting to the ER by penetrating abdominal trauma with imsignificant findings will be managed conservatively.
干预措施: Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children (Procedure)
结局指标
主要结局
Rate of missed injury (number & percent)
时间窗: 1 week
Rate of missed injury
Complications (number & percent)
时间窗: 1 year
Complications
Mortality rate (number & percent)
时间窗: 3 years
Mortality rate
次要结局
- Operative time (in minutes)(1 day (day of surgery))
- Hospital stay (in days)(2 weeks)
- Follow-up period (in months)(3 years)
研究者
dr. Muhammad Abdelhafez Mahmoud, MD
Lecturer of pediatric surgery
Al-Azhar University