NCT01825187

Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: South East Area Health Education Center, Wilmington, NC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Hernia, Inguinal

Interventions

Type	Name	Description
DEVICE	ULTRAPRO Mesh	Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair
DEVICE	3DMAX	Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair
OTHER	Evaluation	To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.

Timeline

• Start date: 2014-06-01
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2013-04-05
• Last updated: 2022-06-14
• Results posted: 2022-06-14

Locations

1 site across 1 country: United States