Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01825187|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2013
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Inguinal||Device: ULTRAPRO Mesh Device: 3DMAX Other: Evaluation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Controlled Trial Comparing Resident Performance and Clinical Outcomes With Two Different Polypropylene Meshes for Laparoscopic Inguinal Hernias|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825187
|United States, North Carolina|
|New Hanover Regional Medical Center|
|Wilmington, North Carolina, United States, 28401|
|Principal Investigator:||William W Hope, MD||South East Area Health Education Center|