Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

Study Overview
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Brief Summary
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The purpose of this research study is to measure the clinical effectiveness of two different polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of hospital stay, perioperative complications, recurrence rate, pain score, comfort level and postoperative quality of life. A secondary goal of the study is to evaluate the ease of use and time it takes surgical residents to place the mesh and perform the surgery using these two different meshes.

Detailed Description
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Inguinal hernia repair is one of the most common operations performed by general surgeons in the world. There are two main ways to repair an inguinal hernia, open or laparoscopic. Open compared to laparoscopic, is more invasive and leads to more scarring and longer recovery periods. Laparoscopic repair is done by making a small cut in or just below the umbilicus and has become an accepted standard for inguinal hernia repair and has become the technique of choice for recurrent inguinal hernias. During laparoscopic repair, the placement of a prosthetic mesh aids in reinforcing the abdominal wall and allowing for tension free repair. Meshes also helps to lower the recurrence rate. The most safe and effective type of mesh prosthesis currently being used in laparoscopic inguinal hernia repairs are polypropylene meshes. There is some emerging evidence that lighter weight forms of polypropylene meshes may improve quality of life outcomes following surgery for inguinal hernias. Further evaluation is needed to support this evidence.

Official Title
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Prospective Randomized Controlled Trial Comparing Resident Performance and Clinical Outcomes With Two Different Polypropylene Meshes for Laparoscopic Inguinal Hernias

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Device: ULTRAPRO Mesh
* Device: 3DMAX
* Other: Evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects undergoing laparoscopic repair for the treatment of either single or bilateral inguinal hernias All surgical residents at New Hanover Regional Medical Center Exclusion Criteria: Subjects requiring emergency surgery Pregnant subjects Subjects under the age of 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group 1<br>Patients in this group will be randomized to receive the ULTRAPRO mesh | Device: ULTRAPRO Mesh<br>* Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair<br>|
| Active Comparator: Treatment Group 2<br>Patients in this group will be randomized to receive the 3DMAX Mesh | Device: 3DMAX<br>* Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair<br>|
| Other: Evaluation of Surgical Residents<br>Surgical residents will be evaluated on the ease of use and the amount of time it takes for them to perform the surgery using these two different meshes. | Other: Evaluation<br>* To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inguinal Hernia Mesh Insertion Times | The primary outcome measure was a comparison of mesh insertion times and were tested using a 2 × 2 ANOVA on the ranked times. Timing of the mesh placement was documented, which included time from mesh insertion in the trocar until completion of mesh fixation. Laparoscopic fixation was performed by placing four tacks; two in the pubic bone, one medial, and one lateral on the upper portion of the mesh. The types of tacks used were AbsorbaTack™ (Medtronics), sutures, CapSure™ (CR Bard) and OptiFix™ (CR Bard). Timing of mesh placement in robotic repairs included mesh placement and the time to place three suture fixation points; one at the pubis, one at the anterior, and 1 at the lateral abdominal wall at the top of the mesh. | During the procedure an average of an hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NASA TLX Survey Index Scores | Following surgery, the Hart and Staveland's NASA Task Load Index (TLX) survey was completed by the surgeon to evaluate the surgeon's perceived difficulty and success of the operation. Scale ranges from very low (0) to very high (20) on a 20 point scale (0-20 points). For all outcome measures except performance, 0 indicates the worst outcome and 20 indicates the best outcome. For performance, 0 indicates perfect and 20 indicates failure. | During procedure an average of 1 hour |