Incisional Hernia in Infants and Children

• Sponsor: Tanta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05005663
• Collaborator: (none)
• Enrollment: 67
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 191.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

the study of development of incisional hernia in infants and children at a tertiary level experience.

Condition or Disease	Intervention/Treatment	Phase
Incisional Hernia	Other: surgical management of incisional hernia	N/A

Detailed Description

Background: incisional hernia in children and infants (IHCI) represents a major complication following exploration. The condition is associated with prolonged hospital stay, readmission and the need for another operation to treat the resulting incisional hernia. The incidence is variable worldwide. The leading causes are still indeterminate as well as the management strategy. We aimed at studying IHCI at a tertiary level hospital as regard presenting symptoms, methods of management and its impact on the quality of life of patients.

Methods: a retrospective study included all infants and children presented with incisional hernia. Patients were categorized in to two groups according to the age of presentation, group A patients younger than two years of age and group B patients older than two years. All data related to the first operation in addition to data related to repair of the incisional hernia were collected in special charts.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 67 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Incisional Hernia in Children and and Infants : a Tertiary Center Experience
• Actual Study Start Date: Feb 2, 2007
• Anticipated Primary Completion Date: Dec 20, 2022
• Anticipated Study Completion Date: Jan 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group A patients younger than 2 years	Other: surgical management of incisional hernia; surgical repair of the incisional hernia
Active Comparator: group B patients older than 2 years	Other: surgical management of incisional hernia; surgical repair of the incisional hernia

Outcome Measures

Primary Outcome Measures

1. repair of incisional hernia [2 years]

   surgical repair

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all infants and children with incisional hernia

Exclusion Criteria:

• congenital abdominal wall defects

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Tanta		Egypt	31111

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammad Gharieb Mohammad Khirallah, assistant professor of pediatric surgery, Tanta University
• ClinicalTrials.gov Identifier: NCT05005663
• Other Study ID Numbers: 34687/5/21
• First Posted: Aug 13, 2021
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohammad Gharieb Mohammad Khirallah, assistant professor of pediatric surgery, Tanta University: incisional hernia; infants; children; tissue repair; wound healing
• Additional relevant MeSH terms: Hernia; Incisional Hernia

Study Results

No Results Posted as of Apr 27, 2022