Mass Closure vs Layer by Layer Closure

Mass Closure vs Layer by Layer Closure of the Transverse Abdominal Laparotomy Incisions in Infants and Children: a Randomized Clinical Trial

to assess two different ways of closure of laparotomy in children and infants

Study Overview

• Status: Recruiting
• Conditions: Ventral Hernia; Incisional Hernia; Abdominal Wall Wound
• Intervention / Treatment: Other: Mass closure vs layer by layer closure of transverse laparotomy incisions 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31111
      • Recruiting
      • Tanta University Hospitals
      • Contact: Nagi E eldessouki, professor; Phone Number: +20 201003546853; Email: "nagi2709Staff" <neldesoky@med.tanta.edu.eg>
      • Principal Investigator: Suzan E Gado, professor
      • Principal Investigator: Nagi E ldessouki, professor
      • Principal Investigator: Radwa M Elkholy, professor
      • Principal Investigator: Mazen O Kurdi, professor
      • Sub-Investigator: Ahmed Moukhtar, specalist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• all infants and children with transverse laparotomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: mass closure; infants and children whose transverse laparotomy incisions will be closed in mass closure.	Other: 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.
Active Comparator: layer by layer closure; infants and children whose transverse laparotomy incisions will be closed layer by layer.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	two weeks up to one month

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: incisional hernia; transverse laparotomy; mass closure; layer by layer closure
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Incisional Hernia
• Other Study ID Numbers: 36264PR286/8/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No