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Incisional Hernia in Infants and Children

Primary Purpose

Incisional Hernia

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

surgical management of incisional hernia

About this trial

This is an interventional treatment trial for Incisional Hernia focused on measuring incisional hernia, infants, children, tissue repair, wound healing

Eligibility Criteria

8 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

all infants and children with incisional hernia

Exclusion Criteria:

congenital abdominal wall defects

Sites / Locations

Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

group A

group B

Arm Description

patients younger than 2 years

patients older than 2 years

Outcomes

Primary Outcome Measures

repair of incisional hernia

surgical repair

Secondary Outcome Measures

Full Information

NCT ID

NCT05005663

First Posted

August 5, 2021

Last Updated

April 26, 2022

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT05005663

Brief Title

Incisional Hernia in Infants and Children

Official Title

Incisional Hernia in Children and and Infants : a Tertiary Center Experience

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 2, 2007 (Actual)

Primary Completion Date

December 20, 2022 (Anticipated)

Study Completion Date

January 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Incisional Hernia

Keywords

incisional hernia, infants, children, tissue repair, wound healing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Active Comparator

Arm Description

patients younger than 2 years

Arm Title

group B

Arm Type

Active Comparator

Arm Description

patients older than 2 years

Intervention Type

Other

Intervention Name(s)

surgical management of incisional hernia

Intervention Description

surgical repair of the incisional hernia

Primary Outcome Measure Information:

Title

repair of incisional hernia

Description

surgical repair

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: all infants and children with incisional hernia Exclusion Criteria: congenital abdominal wall defects

Facility Information:

Facility Name

Faculty of Medicine

City

Tanta

ZIP/Postal Code

31111

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nagi El-dessouky

neldesoky2000@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Incisional Hernia in Infants and Children

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