Mass Closure vs Layer by Layer Closure

NCT ID: NCT06016426

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-11-30

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.

Conditions

Abdominal Wall Wound; Ventral Hernia; Incisional Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

mass closure

infants and children whose transverse laparotomy incisions will be closed in mass closure.

Group Type: ACTIVE_COMPARATOR

Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.

Intervention Type: OTHER

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.

layer by layer closure

infants and children whose transverse laparotomy incisions will be closed layer by layer.

Group Type: ACTIVE_COMPARATOR

Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.

Intervention Type: OTHER

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.

Interventions

Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• all infants and children with transverse laparotomy

Exclusion Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Gharieb Mohammad Khirallah

professor of pediatric surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospitals

Tanta, Gharbia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Nagi E eldessouki, professor

Role: primary

"nagi2709Staff" <neldesoky@med.tanta.edu.eg>

+20 201003546853

Other Identifiers

36264PR286/8/23

Identifier Type: -

Identifier Source: org_study_id