Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016426
Status:
RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-08-18
Brief Title:
Mass Closure vs Layer by Layer Closure
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Mass Closure vs Layer by Layer Closure of the Transverse Abdominal Laparotomy Incisions in Infants and Children a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-08
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:
None
Brief Summary:
to assess two different ways of closure of laparotomy in children and infants
Detailed Description:
Introduction
The technique of abdominal wall closure in infants subjected to abdominal transverse laparotomy incision may have an impact not only on the development of a future incisional hernia but also on the function of the anterior abdominal wall muscles
There are two ways to close this laparotomy incision These ways are either closure in mass or layer by layer closure Neither of them is superior to the other
The main issue that minds the pediatric surgeons is a safe and successful repair of the abdominal wall incision and the avoidance of the development of incisional hernia
The aim of this work is to randomly compare the two different techniques of the closure of transverse laparotomy incision
Patients and methods
- Study design The study was performed during the period from January 2020 to October 2024 It is a randomized control trial
Inclusion criteria were infants younger than 3 years We excluded infants with history of prematurity previous abdominal operations and infants with congenital abdominal wall defects
An informed consent was obtained from the parents or the care giver of every participant
Randomization was obtained using closed envelop method Patients were categorized into two groups A and B Group A included patients that their exploratory wound was closed with mass closure method using Vicryl 20 round needle Group B included patients that their exploratory wound was closed layer by layer using the same suture material
In both groups the ratio of the suture length to the wound was 3 to 1 - The measured variables The variables that were addressed were
1 the mean operative time in minutes
2 the incidence of wound dehiscence
3 the occurrence of wound infection
4 The development of an incisional hernia
5 Long term assessment of both abdominal wall structure and dynamics of abdominal muscles at the site of incision
Follow up protocol
All patients were scheduled on a follow up regimen They were examined weekly for one month post-operative Then monthly for one year The anterior abdominal wall of these patients was examined by ultrasound at the 6th and 12th moth postoperatively This helped assessment of the dynamics and structure of the muscles at the site of the incision
- Statistical analysis Statistical analysis was conducted using SPSS statistical package ver 21 IBM SPSS NY USA Numerical data were compared using an independent sample t-test whereas categorical data were compared using the chi-square test Statistical significance was set at p 005
The technique of abdominal wall closure in infants subjected to abdominal transverse laparotomy incision may have an impact not only on the development of a future incisional hernia but also on the function of the anterior abdominal wall muscles
There are two ways to close this laparotomy incision These ways are either closure in mass or layer by layer closure Neither of them is superior to the other
The main issue that minds the pediatric surgeons is a safe and successful repair of the abdominal wall incision and the avoidance of the development of incisional hernia
The aim of this work is to randomly compare the two different techniques of the closure of transverse laparotomy incision
Patients and methods
- Study design The study was performed during the period from January 2020 to October 2024 It is a randomized control trial
Inclusion criteria were infants younger than 3 years We excluded infants with history of prematurity previous abdominal operations and infants with congenital abdominal wall defects
An informed consent was obtained from the parents or the care giver of every participant
Randomization was obtained using closed envelop method Patients were categorized into two groups A and B Group A included patients that their exploratory wound was closed with mass closure method using Vicryl 20 round needle Group B included patients that their exploratory wound was closed layer by layer using the same suture material
In both groups the ratio of the suture length to the wound was 3 to 1 - The measured variables The variables that were addressed were
1 the mean operative time in minutes
2 the incidence of wound dehiscence
3 the occurrence of wound infection
4 The development of an incisional hernia
5 Long term assessment of both abdominal wall structure and dynamics of abdominal muscles at the site of incision
Follow up protocol
All patients were scheduled on a follow up regimen They were examined weekly for one month post-operative Then monthly for one year The anterior abdominal wall of these patients was examined by ultrasound at the 6th and 12th moth postoperatively This helped assessment of the dynamics and structure of the muscles at the site of the incision
- Statistical analysis Statistical analysis was conducted using SPSS statistical package ver 21 IBM SPSS NY USA Numerical data were compared using an independent sample t-test whereas categorical data were compared using the chi-square test Statistical significance was set at p 005
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