Clinical trial NCT01825187: Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias
Official title: Prospective Randomized Controlled Trial Comparing Resident Performance and Clinical Outcomes With Two Different Polypropylene Meshes for Laparoscopic Inguinal Hernias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Lead sponsor: South East Area Health Education Center, Wilmington, NC
Sponsor class: OTHER
Collaborators: name: New Hanover Regional Medical Center
First posted: 2013-04-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inguinal Hernia Mesh Insertion Times
timeFrame: During the procedure an average of an hour
Secondary outcomes:
measure: NASA TLX Survey Index Scores
timeFrame: During procedure an average of 1 hour
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
Study officials:
affiliation: South East Area Health Education Center
name: William W Hope, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bilezikian JA, Tenzel PL, Johnson RG, Powers WF 4th, Hope WW. A preliminary evaluation of two different meshes in minimally invasive inguinal hernia surgery. Surg Endosc. 2021 Mar;35(3):1342-1347. doi: 10.1007/s00464-020-07512-9. Epub 2020 Mar 30.