- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02240550
A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
A Prospective, Randomized, Double-armed, Single-blinded, Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Pune, India
- Healing Hands Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ProFlor Hernia Repair System
A 3-D hernia mesh
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The 3-D hernia mesh will be used in the repair of your inguinal hernia.
Other Names:
|
Active Comparator: Lichtenstein Hernia Repair
Using flat polypropylene mesh
|
The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month
|
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.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identify any short-term related complication/adverse events associated with the procedures.
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Murphy, MD, Healing Hands Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0133
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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