Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04580875
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2020-09-29
Brief Title:
Role of Minimally Invasive Surgery in Management of Penetrating Abdominal Trauma in Children
Sponsor:
dr Muhammad Abdelhafez Mahmoud MD
Organization:
Al-Azhar University
Study Overview
Official Title:
Role of Minimally Invasive Surgery in Management of Penetrating Abdominal Trauma in Children
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MISinPAT
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 7306 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
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 7306 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 Childrens 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 Childrens 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 521712 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 240 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 Fishers exact test was used for comparison of frequency countspercentage The t test was used for comparison of mean values A two-sided p value less than 005 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
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 Childrens 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 Childrens 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 521712 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 240 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 Fishers exact test was used for comparison of frequency countspercentage The t test was used for comparison of mean values A two-sided p value less than 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None