An interventional study of Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants. in Abdominal Wall Wound, Ventral Hernia and Incisional Hernia, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 3 Months to 1 Year. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Tanta University · Not applicable, Interventional, and Prevention
to assess two different ways of closure of laparotomy in children and infants
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:
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
Long term assessment of both abdominal wall structure and dynamics of abdominal muscles at the site of incision.
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.
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Exclusion Criteria:
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.
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.
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
Time frame: one year
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
Time frame: two weeks up to one month
Plan to share: Undecided
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