Mass Closure vs Layer by Layer Closure

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016426
• Other study ID #: 36264PR286/8/23
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 30, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 1 Year

Eligibility

Inclusion Criteria:

• all infants and children with transverse laparotomy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Abdominal Wall Wound
• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Hernia

Intervention

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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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