NCT05005663

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2007

Completed
14.5 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2023

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

15.9 years

First QC Date

August 5, 2021

Last Update Submit

April 26, 2022

Conditions

Incisional Hernia

Keywords

incisional herniainfantschildrentissue repairwound healing

Outcome Measures

Primary Outcomes (1)

  • repair of incisional hernia

    surgical repair

    2 years

Study Arms (2)

group A

ACTIVE COMPARATOR

patients younger than 2 years

Other: surgical management of incisional hernia

group B

ACTIVE COMPARATOR

patients older than 2 years

Other: surgical management of incisional hernia

Interventions

surgical management of incisional herniaOTHER

surgical repair of the incisional hernia

group Agroup B

Eligibility Criteria

Age8 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • all infants and children with incisional hernia

You may not qualify if:

  • congenital abdominal wall defects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Tanta, 31111, Egypt

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of pediatric surgery

Study Record Dates

First Submitted

August 5, 2021

First Posted

August 13, 2021

Study Start

February 2, 2007

Primary Completion

December 20, 2022

Study Completion

January 22, 2023

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations

EG(1)