Type of Material in Repair of Congenital Diaphragmatic Hernia
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|ClinicalTrials.gov Identifier: NCT00257946|
Recruitment Status : Terminated (poor accrual)
First Posted : November 24, 2005
Last Update Posted : December 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Congenital Diaphragmatic Hernia||Procedure: Repair of CDH w/SIS Gold Procedure: Repair of CDH w/Alloderm||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial Comparing Type of Material in Repair of Congenital Diaphragmatic Hernia|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
- Recurrence of Diaphragmatic Hernia
- Bowel Obstruction
- Ventilatory days
- Ventilatory status at follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257946
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shawn D St. Peter, MD||Children's Mercy Hospital|