Type of Material in Repair of Congenital Diaphragmatic Hernia

2014-08-27 03:47:29 | BioPortfolio


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.


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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Congenital Diaphragmatic Hernia


Repair of CDH w/SIS Gold, Repair of CDH w/Alloderm


Children's Mercy Hospital
Kansas City
United States




Children's Mercy Hospital Kansas City

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:47:29-0400

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Medical and Biotech [MESH] Definitions

The type of DIAPHRAGMATIC HERNIA caused by TRAUMA or injury, usually to the ABDOMEN.

The reconstruction of a continuous two-stranded DNA molecule without mismatch from a molecule which contained damaged regions. The major repair mechanisms are excision repair, in which defective regions in one strand are excised and resynthesized using the complementary base pairing information in the intact strand; photoreactivation repair, in which the lethal and mutagenic effects of ultraviolet light are eliminated; and post-replication repair, in which the primary lesions are not repaired, but the gaps in one daughter duplex are filled in by incorporation of portions of the other (undamaged) daughter duplex. Excision repair and post-replication repair are sometimes referred to as "dark repair" because they do not require light.

Protrusion of abdominal structures into the THORAX as a result of congenital or traumatic defects in the respiratory DIAPHRAGM.

A DNA repair enzyme that catalyzes DNA synthesis during base excision DNA repair. EC

The repair of DOUBLE-STRAND DNA BREAKS by rejoining the broken ends of DNA to each other directly.

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