Mass Closure vs Layer by Layer Closure

NCT06016426 | Unknown

• 1 other identifier: 36264PR286/8/23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominal Wall Wound; Ventral Hernia; Incisional Hernia

Keywords

transverse laparotomy; incisional hernia; mass closure; layer by layer closure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• surgical site infections

  two weeks up to one month

Study Arms (2)

mass closure

ACTIVE COMPARATOR

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.

layer by layer closure

ACTIVE COMPARATOR

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.

Interventions

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

Eligibility Criteria

• Age: 3 Months - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• all infants and children with transverse laparotomy

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31111, Egypt

RECRUITING

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of pediatric surgery

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 29, 2023
• Study Start: September 30, 2023
• Primary Completion: October 31, 2024
• Study Completion: November 30, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

EG (1)