Umbilical Hernia
Conditions
Keywords
Minimally invasive surgery, Umbilical hernia, Infant
Brief 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.
Interventions
DEVICEDeflux
Patients undergo surgery using Deflux to correct umbilical hernia
Sponsors
Q-Med Scandinavia, Inc.
South Shore Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 1-5 years * Umbilical hernia\>1cm. diameter. * Undergoing either a general surgical or urologic procedure under general anesthesia other than umbilical hernia repair. * No previous umbilical hernia repair.
Exclusion criteria
* Over 5 years * No umbilical hernia * No other surgery required * Previous umbilical hernia repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Close Belly Button or Umbilical Hernia | After surgery, subjects will be followed at intervals of one month and six months from date of surgery. | 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. |
Countries
United States
Participant flow
Recruitment details
physician office
Pre-assignment details
59 medical records were screened; 25 were eligible and received Deflux
Participants by arm
| Arm | Count |
|---|---|
| Deflux Treatment with Deflux. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Close Belly Button or Umbilical Hernia
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.
Time frame: After surgery, subjects will be followed at intervals of one month and six months from date of surgery.