Minimally Invasive Closure of Umbilical Hernias

Umbilical Hernia Clinical Trial

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Official title:

Study of Minimally Invasive Closure of Umbilical Hernias

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00706329
• Other study ID #: SSH ID 07-003
• Status: Terminated
• Phase: N/A
• First received: June 25, 2008
• Last updated: October 4, 2017
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2017
• Source: South Shore Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00839618

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Umbilical Hernia

Intervention

Device:
• Deflux
Patients undergo surgery using Deflux to correct umbilical hernia

Locations

Country	Name	City	State
United States	Children's Hospital Boston and South Shore Hospital	South Weymouth	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
South Shore Hospital	Q-Med Scandinavia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	After surgery, subjects will be followed at intervals of one month and six months from date of surgery.