NCT00257946

Type of Material in Repair of Congenital Diaphragmatic Hernia

Prospective Randomized Trial Comparing Type of Material in Repair of Congenital Diaphragmatic Hernia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 2 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Diaphragmatic Hernia

Interventions

Type	Name	Description
PROCEDURE	Repair of CDH w/SIS Gold
PROCEDURE	Repair of CDH w/Alloderm

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2005-11-24
• Last updated: 2011-12-15

Locations

1 site across 1 country: United States