Clinical Trial: Type of Material in Repair of Congenital Diaphragmatic Hernia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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 recorde
Sponsor: Children's Mercy Hospital Kansas City

Current Primary Outcome: Recurrence of Diaphragmatic Hernia

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bowel Obstruction
  • Ventilatory days
  • Ventilatory status at follow-up


Original Secondary Outcome: Same as current

Information By: Children's Mercy Hospital Kansas City

Dates:
Date Received: November 22, 2005
Date Started: December 2005
Date Completion:
Last Updated: December 14, 2011
Last Verified: December 2011