Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257946
Status:
TERMINATED
Last Update Posted:
2011-12-15
First Post:
2005-11-22
Brief Title:
Type of Material in Repair of Congenital Diaphragmatic Hernia
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Prospective Randomized Trial Comparing Type of Material in Repair of Congenital Diaphragmatic Hernia
Status:
TERMINATED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the use of 2 different types of biosynthetic material for the repair of congenital diaphragmatic hernia The research question is what is the best material for repairing large congenital diaphragmatic hernias The primary outcome variable is recurrence
Detailed Description:
At birth the estimated gestational age and birth weight will be recorded as well as the presence and type of other congenital anomalies
Prior to operation the length of time from birth to repair will be recorded To determine the severity of physiologic compromise the need and type of ventilator support as well as the need and length of ECMO support will be recorded The amount of time between ECMO discontinuation and repair will be recorded The respiratory support required at the time of operation will be recorded
At operation the size of the defect will be measured and recorded The location right versus left will be recorded and special notation will be recorded regarding any areas where no diaphragmatic rim is present The operative time and charges will be recorded
After the operation the length of ventilator support time to feeds hospital stay and hospital charges will be recorded Post-operative complications such as bleeding complications pneumonia sepsis gastroesophageal reflux early recurrence and bowel obstruction will be recorded Future operations and type of procedure will be recorded If future operations in the abdomen are required the amount and severity of intraperitoneal adhesions will be noted and recorded Mortality will be recorded
After discharge commensurate with standard current clinical practice all patients will receive a follow-up appointment with a chest x-ray at 6 months and 1 year of life After this time follow-up appointments will be made each year for the first 5 years of life and imaging will be obtained on the basis of symptoms Any further follow-up will be as needed for symptoms Oxygen requirements findings at follow-up and future hospitalization will be recorded particularly looking at the presence or absence of hernia recurrence The study will mature and effectively close when all subjects have reached 5 year follow-up
Prior to operation the length of time from birth to repair will be recorded To determine the severity of physiologic compromise the need and type of ventilator support as well as the need and length of ECMO support will be recorded The amount of time between ECMO discontinuation and repair will be recorded The respiratory support required at the time of operation will be recorded
At operation the size of the defect will be measured and recorded The location right versus left will be recorded and special notation will be recorded regarding any areas where no diaphragmatic rim is present The operative time and charges will be recorded
After the operation the length of ventilator support time to feeds hospital stay and hospital charges will be recorded Post-operative complications such as bleeding complications pneumonia sepsis gastroesophageal reflux early recurrence and bowel obstruction will be recorded Future operations and type of procedure will be recorded If future operations in the abdomen are required the amount and severity of intraperitoneal adhesions will be noted and recorded Mortality will be recorded
After discharge commensurate with standard current clinical practice all patients will receive a follow-up appointment with a chest x-ray at 6 months and 1 year of life After this time follow-up appointments will be made each year for the first 5 years of life and imaging will be obtained on the basis of symptoms Any further follow-up will be as needed for symptoms Oxygen requirements findings at follow-up and future hospitalization will be recorded particularly looking at the presence or absence of hernia recurrence The study will mature and effectively close when all subjects have reached 5 year follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None