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Minimally Invasive Closure of Umbilical Hernias (MIC)
This study is currently recruiting participants.
Verified by South Shore Hospital, June 2008
Sponsors and Collaborators: South Shore Hospital
Q-Med Scandinavia, Inc.
Information provided by: South Shore Hospital
ClinicalTrials.gov Identifier: NCT00706329
  Purpose

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.


Condition Intervention
Umbilical Hernia
Device: Deflux

MedlinePlus related topics: Hernia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Study of Minimally Invasive Closure of Umbilical Hernias

Further study details as provided by South Shore Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: April 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Deflux
    Patients undergo surgery using Deflux to correct 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

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706329

Contacts
Contact: Neil R Feins, M.D. 617-355-8915 Neil.Feins@childrens.harvard.edu
Contact: Elizabeth Pennachio 617-355-8915 elizabeth.pennachio@childrens.harvard.edu

Locations
United States, Massachusetts
South Shore Hospital Recruiting
South Weymouth, Massachusetts, United States, 02190
Principal Investigator: Neil R Feins, M.D.            
Sponsors and Collaborators
South Shore Hospital
Q-Med Scandinavia, Inc.
Investigators
Principal Investigator: Neil R. Feins, M.D. South Shore Hospital
  More Information

Responsible Party: South Shore Hospital ( Neil R. Feins, M.D. )
Study ID Numbers: SSH ID 07-003
Study First Received: June 25, 2008
Last Updated: June 26, 2008
ClinicalTrials.gov Identifier: NCT00706329  
Health Authority: United States: Food and Drug Administration

Keywords provided by South Shore Hospital:
Minimally invasive surgery
Umbilical hernia
Infant

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Hernia, Umbilical
Hernia, Ventral
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on January 16, 2009