Clinical trial NCT00706329: Minimally Invasive Closure of Umbilical Hernias
Official title: Study of Minimally Invasive Closure of Umbilical Hernias
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Umbilical Hernia
Keywords: Minimally invasive surgery
Umbilical hernia
Infant
Lead sponsor: South Shore Hospital
Sponsor class: OTHER
Collaborators: name: Q-Med Scandinavia, Inc.
First posted: 2008-06-27
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Close Belly Button or Umbilical Hernia
timeFrame: After surgery, subjects will be followed at intervals of one month and six months from date of surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: South Weymouth
country: United States
facility: Children's Hospital Boston and South Shore Hospital
state: Massachusetts
Study officials:
affiliation: Children's Hospital Boston and South Shore Hospital
name: Neil R. Feins, M.D.
role: PRINCIPAL_INVESTIGATOR
References: