A Prospective, Randomized, Double-armed, Single-blinded, Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Inguinal Hernia
- Sponsor
- Insightra Medical, Inc.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Evaluate the immediate and short-term amount of pain.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Evaluate the immediate and short-term amount of pain.
Time Frame: 1 month
We will evaluate the immediate and short-term amount of pain using the VAS and Carolinas Comfort Scale (CCS) assessments held at regular intervals.
Compare the time required for return to normal activities (work).
Time Frame: 1 month
We will capture the time required to return to normal activities as indicated by the patient.
Secondary Outcomes
- Identify any short-term related complication/adverse events associated with the procedures.(1 month)