A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair

Insightra Medical

Status

Completed

Conditions

Inguinal Hernia

Treatments

Device: ProFlor Hernia Repair System

Device: Lichtenstein hernia repair

Study type

Interventional

Funder types

Industry

Identifiers

NCT02240550

P0133

Details and patient eligibility

About

This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair.

Full description

The primary objectives of this study will be to evaluate the immediate and short-term amount of post-operative pain, the quality of life (QOL), as well as return to normal activities (work) for the two procedures. Carolinas Comfort Scale (CCS) and Visual Analogue Score (VAS) assessments will be held at regular intervals to evaluate these objectives.

The secondary objective of the study is to identify any short-term study related complications/adverse events.

The follow up will be immediately post-operative, post-operative day 1, and 1, 2,and 4 weeks. The first and 4th week's visits are mandatory office visits (if possible). If not available for office visit, a CCS assessment will be mailed or will be conducted via phone.

Up to 50 patients may be enrolled for this study (25 per arm). A report may be generated for presentation at an international meeting such as the AHS, EHS, or APHS if decided by the lead investigator.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Scheduled to undergo routine inguinal hernia repair
Male and Female patients between 18 and 65 years old
Competent to give consent
Clinically relevant inguinal hernia (classification: EHS P L/M 1/2/3)
Defect size at operation is between 5mm and 35mm
Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
Primary hernia at the operative site

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 or Nursing women
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
Patient has a clinically relevant co-morbidity (antithrombic prophylaxis due to cardiovascular pathologies, diabetes requiring insulin therapy or immunodeficiency syndrome of any type)
Neutropenia with absolute neutrophil count (ANC)<500 cells/mm3
Significant of life-threatening condition (e.g., endocarditis) that would confound or interfere with the procedure
Patients that require anticoagulant monitoring with an activated partial thromboplastin time (aPTT)
Patients unwilling to forego blood and/or blood product donation for at least 3 months from initiation of first study device
Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
Investigational device present, or removed within 30 days before enrollment, or presence of device-related infection
Patients who the investigator considers unlikely to adhere to the protocol or complete the clinical study