NCT00706329

Minimally Invasive Closure of Umbilical Hernias

Study of Minimally Invasive Closure of Umbilical Hernias

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: South Shore Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Umbilical Hernia

Interventions

Type	Name	Description
DEVICE	Deflux	Patients undergo surgery using Deflux to correct umbilical hernia

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-06-27
• Last updated: 2017-11-06
• Results posted: 2013-08-28

Locations

1 site across 1 country: United States