Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

South East Area Health Education Center, Wilmington, NC

Status: Completed

Conditions: Hernia, Inguinal

Treatments: Device: ULTRAPRO Mesh; Device: 3DMAX; Other: Evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT01825187

1302-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Treatment Group 1

Active Comparator group

Description:

Patients in this group will be randomized to receive the ULTRAPRO mesh

Treatment:

Device: ULTRAPRO Mesh

Treatment Group 2

Active Comparator group

Description:

Patients in this group will be randomized to receive the 3DMAX Mesh

Treatment:

Device: 3DMAX

Evaluation of Surgical Residents

Other group

Description:

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.

Treatment:

Other: Evaluation