Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Controlled Trial Comparing Resident Performance and Clinical Outcomes With Two Different Polypropylene Meshes for Laparoscopic Inguinal Hernias|
- To evaluate the clinical effectiveness of two currently used meshes for inguinal hernias [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Treatment Group 1
Patients in this group will be randomized to receive the ULTRAPRO mesh
Device: ULTRAPRO Mesh
Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair
Active Comparator: Treatment Group 2
Patients in this group will be randomized to receive the 3DMAX Mesh
Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair
Evaluation of Surgical Residents
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.
To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01825187
|Contact: Joan G Garrison, BA, CCRP||910.667.3194||Joan.Garrison@seahec.net|
|United States, North Carolina|
|New Hanover Regional Medical Center||Recruiting|
|Wilmington, North Carolina, United States, 28401|
|Contact: Joan G Garrison, BA, CCRP 910-667-3194 Joan.Garrison@seahec.net|
|Principal Investigator:||William W Hope, MD||South East Area Health Education Center|