Clinical trial NCT06016426: 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
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Wall Wound
Ventral Hernia
Incisional Hernia
Keywords: transverse laparotomy
incisional hernia
mass closure
layer by layer closure
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 \<0.05.

Eligibility criteria: Inclusion Criteria:

* all infants and children with transverse laparotomy

Exclusion Criteria:

* previous abdominal operations
* children and infants with congenital abdominal wall defects

Primary outcomes:
measure: wound failure with the development of incisional hernia later in either group
timeFrame: one year
Secondary outcomes:
measure: surgical site infections
timeFrame: two weeks up to one month
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbia
Study officials:
References: