Minimally Invasive Closure of Umbilical Hernias (MIC)
The purpose of the study is to test the use of "Deflux" injections in a minimally invasive closure of umbilical (belly button) hernias in infants between birth and five years. The study is designed to demonstrate that the use of this device can safely and effectively close an umbilical hernia.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Minimally Invasive Closure of Umbilical Hernias|
- Close Belly Button or Umbilical Hernia [ Time Frame: After surgery, subjects will be followed at intervals of one month and six months from date of surgery. ] [ Designated as safety issue: No ]The study was terminated prematurely by the IRB. Results are not shared due to data integrity concerns. These concerns are outlined in an FDA warning letter.
- At Follow up if the Hernia Has Not Closed, Another Surgery May be Required to Close the Umbilical Hernia. [ Time Frame: Seven or more months after initial surgery. ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Treatment with Deflux.
Patients undergo surgery using Deflux to correct umbilical hernia
Other Name: Deflux
All patients will undergo general anesthesia for their primary procedure, i.e. inguinal hernia repair. Once under general anesthesia, the abdomen will be prepped and draped in the usual sterile surgical fashion. The edge of the umbilical hernia defect will be palpated and in case there are any contents of the hernia present, they will be pushed into the abdominal cavity. Adequate relaxation, again, will be assured. A 24 gauge needle will be used to inject 1cc of Deflux ("Study Product") into each quadrant at the junction between the preperitoneal space and the inner palpable rim of the fascial defect. The surgeon's index finger stays in the center of the hernia defect, protecting the hernia sac contents from re-herniating. Closure of the umbilical defect will be confirmed by palpation immediately after injection. A sterile wound dressing will be applied and the primary surgical procedure will be performed afterwards.
Definition of Primary and Secondary Outcomes/Endpoints:
The endpoint of this study is closure of the umbilical hernia.
Data Collection Methods, Assessments, and Schedule (what assessments performed, how often): A data collection file is started at the time of enrollment in the study. Data collection includes patient age, gender, and weight at the time of operation, inner diameter of the umbilical hernia defect at the time of operation, description of the immediate postoperative results and follow-up exams at two weeks, one month, and six months.
|United States, Massachusetts|
|Children's Hospital Boston and South Shore Hospital|
|South Weymouth, Massachusetts, United States, 02190|
|Principal Investigator:||Neil R. Feins, M.D.||Children's Hospital Boston and South Shore Hospital|