Freedom Inguinal Hernia Repair System Study

Status:	Active, not recruiting
Conditions:	Gastrointestinal, Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	December 2013

The primary objective of this study is to evaluate patient quality-of-life (QOL) after
inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular
intervals.

The secondary objective of the study is to follow short-term and long-term study-related
complications/adverse events.

Inclusion Criteria:

- Scheduled to undergo routine inguinal hernia repair

- Competent to give consent

- Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa)

- Defect size at operation is between 5mm and 35mm

- Diagnosed with unilateral, direct, indirect or mixed inguinal hernia

- Primary hernia at the operative site

- Male or female

- Life expectancy of at least 12 months

- At least 18 years of age

Exclusion Criteria:

- Signs of obvious local or systemic infection

- Any previous surgery on the hernia operative site

- Hernia is not in the inguinal area

- Hernia is not identified as indirect or direct

- Femoral hernias

- Known collagen disorder

- Presenting with unstable angina or NYHA class of IV

- Known Pregnancy

- Active drug user

- Recurrence of a repair by any method

- Patients with giant inguinoscrotal hernia or abdominal wall defect >35 mm in diameter
- e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3

- Immunosuppression, prednisone>15 mg/day, active chemotherapy

- End stage renal disease

- Abdominal ascites

- Skin infection in area of surgical field

- BMI >35

- Peritoneum cannot be closed

We found this trial at

sites

Witham Health Services

Lebanon, Indiana 46052

from

Lebanon, IN