Mass Closure vs Layer by Layer Closure
Primary Purpose
Abdominal Wall Wound, Ventral Hernia, Incisional Hernia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.
Sponsored by
About this trial
This is an interventional prevention trial for Abdominal Wall Wound focused on measuring transverse laparotomy, incisional hernia, mass closure, layer by layer closure
Eligibility Criteria
Inclusion Criteria: all infants and children with transverse laparotomy Exclusion Criteria: previous abdominal operations children and infants with congenital abdominal wall defects
Sites / Locations
- Tanta University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
mass closure
layer by layer closure
Arm Description
infants and children whose transverse laparotomy incisions will be closed in mass closure.
infants and children whose transverse laparotomy incisions will be closed layer by layer.
Outcomes
Primary Outcome Measures
wound failure with the development of incisional hernia later in either group
the occurrence or development of the incisional hernia is the primary outcome. the incidence of the development of this hernia will be recorded in each group. this will help choose the more appropriate method of transverse laparotomy closure in infants and children
Secondary Outcome Measures
surgical site infections
the number of patients who will develop a surgical site infections in each group, the mean duration of hospital stay if this happened. the number of patients who will later develop an incisional hernia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06016426
Brief Title
Mass Closure vs Layer by Layer Closure
Official Title
Mass Closure vs Layer by Layer Closure of the Transverse Abdominal Laparotomy Incisions in Infants and Children: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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® 2/0 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
the mean operative time in minutes,
the incidence of wound dehiscence,
the occurrence of wound infection,
The development of an incisional hernia
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 <0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Wall Wound, Ventral Hernia, Incisional Hernia
Keywords
transverse laparotomy, incisional hernia, mass closure, layer by layer closure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mass closure
Arm Type
Active Comparator
Arm Description
infants and children whose transverse laparotomy incisions will be closed in mass closure.
Arm Title
layer by layer closure
Arm Type
Active Comparator
Arm Description
infants and children whose transverse laparotomy incisions will be closed layer by layer.
Intervention Type
Other
Intervention Name(s)
Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.
Intervention Description
the transverse laparotomy incision in infants and children will be either closed as single layer included the peritoneum, posterior rectus sheath and anterior rectus sheath wit muscle sparing, or the laparotomy will be closed in layer by layer in which the peritoneum and posterior rectus sheath are closed as a layer and the anterior rectus sheath is closed as a seprate layer.
Primary Outcome Measure Information:
Title
wound failure with the development of incisional hernia later in either group
Description
the occurrence or development of the incisional hernia is the primary outcome. the incidence of the development of this hernia will be recorded in each group. this will help choose the more appropriate method of transverse laparotomy closure in infants and children
Time Frame
one year
Secondary Outcome Measure Information:
Title
surgical site infections
Description
the number of patients who will develop a surgical site infections in each group, the mean duration of hospital stay if this happened. the number of patients who will later develop an incisional hernia
Time Frame
two weeks up to one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all infants and children with transverse laparotomy
Exclusion Criteria:
previous abdominal operations
children and infants with congenital abdominal wall defects
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nagi E eldessouki, professor
Phone
+20 201003546853
Email
"nagi2709Staff" <neldesoky@med.tanta.edu.eg>
First Name & Middle Initial & Last Name & Degree
Suzan E Gado, professor
First Name & Middle Initial & Last Name & Degree
Nagi E ldessouki, professor
First Name & Middle Initial & Last Name & Degree
Radwa M Elkholy, professor
First Name & Middle Initial & Last Name & Degree
Mazen O Kurdi, professor
First Name & Middle Initial & Last Name & Degree
Ahmed Moukhtar, specalist
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mass Closure vs Layer by Layer Closure
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