Inguinal Hernia Clinical Trial
Official title:
A Prospective, Randomized, Double-armed, Single-blinded, Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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