Prospective Randomized Controlled Trial Comparing Resident Performance and Clinical Outcomes With Two Different Polypropylene Meshes for Laparoscopic Inguinal Hernias
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hernia, Inguinal
- Sponsor
- South East Area Health Education Center, Wilmington, NC
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Inguinal Hernia Mesh Insertion Times
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 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.
Investigators
William Hope
Director of Surgical Education/Assistant Professor of Surgery
South East Area Health Education Center, Wilmington, NC
Eligibility Criteria
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
Outcomes
Primary Outcomes
Inguinal Hernia Mesh Insertion Times
Time Frame: During the procedure an average of an hour
The primary outcome measure was a comparison of mesh insertion times and were tested using a 2 × 2 ANOVA on the ranked times. Timing of the mesh placement was documented, which included time from mesh insertion in the trocar until completion of mesh fixation. Laparoscopic fixation was performed by placing four tacks; two in the pubic bone, one medial, and one lateral on the upper portion of the mesh. The types of tacks used were AbsorbaTack™ (Medtronics), sutures, CapSure™ (CR Bard) and OptiFix™ (CR Bard). Timing of mesh placement in robotic repairs included mesh placement and the time to place three suture fixation points; one at the pubis, one at the anterior, and 1 at the lateral abdominal wall at the top of the mesh.
Secondary Outcomes
- NASA TLX Survey Index Scores(During procedure an average of 1 hour)