Clinical Trial: Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: South East Area Health Education Center, Wilmington, NC

Current Primary Outcome: To evaluate the clinical effectiveness of two currently used meshes for inguinal hernias [ Time Frame: 2 years ]

The primary purpose of this research study is to evaluate the clinical effectiveness and/or to provide evidence of whether or not one polypropylene mesh is more effective than the other. This will be done by measuring whether or not a "lighter weight" form of a polypropylene mesh may improve a patient's quality of life outcomes following laparoscopic inguinal hernia surgery.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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. [ Time Frame: 2 years ]

This information may make it possible to determine if one mesh is easier for residents to use during surgery and therefore take them less time to perform the surgical procedure. This information may aid in lessening the amount of time the patient spends in the operating room thus lowering medical costs as well as improving patient outcomes.


Original Secondary Outcome: 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. [ Time Frame: 2 years ]

This information may make it possible to determine if one mesh is easier for residents to use during surgery and therefore take them less time to perform the surgical procedure.


Information By: South East Area Health Education Center, Wilmington, NC

Dates:
Date Received: March 8, 2013
Date Started: June 2014
Date Completion: December 2017
Last Updated: November 29, 2016
Last Verified: November 2016