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Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ULTRAPRO Mesh
3DMAX
Evaluation
Sponsored by
South East Area Health Education Center, Wilmington, NC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New Hanover Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Treatment Group 1

Treatment Group 2

Evaluation of Surgical Residents

Arm Description

Patients in this group will be randomized to receive the ULTRAPRO mesh

Patients in this group will be randomized to receive the 3DMAX Mesh

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.

Outcomes

Primary Outcome Measures

Inguinal Hernia Mesh Insertion Times
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 Outcome Measures

NASA TLX Survey Index Scores
Following surgery, the Hart and Staveland's NASA Task Load Index (TLX) survey was completed by the surgeon to evaluate the surgeon's perceived difficulty and success of the operation. Scale ranges from very low (0) to very high (20) on a 20 point scale (0-20 points). For all outcome measures except performance, 0 indicates the worst outcome and 20 indicates the best outcome. For performance, 0 indicates perfect and 20 indicates failure.

Full Information

First Posted
March 8, 2013
Last Updated
June 8, 2022
Sponsor
South East Area Health Education Center, Wilmington, NC
Collaborators
New Hanover Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01825187
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South East Area Health Education Center, Wilmington, NC
Collaborators
New Hanover Regional Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1
Arm Type
Active Comparator
Arm Description
Patients in this group will be randomized to receive the ULTRAPRO mesh
Arm Title
Treatment Group 2
Arm Type
Active Comparator
Arm Description
Patients in this group will be randomized to receive the 3DMAX Mesh
Arm Title
Evaluation of Surgical Residents
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ULTRAPRO Mesh
Intervention Description
Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair
Intervention Type
Device
Intervention Name(s)
3DMAX
Intervention Description
Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair
Intervention Type
Other
Intervention Name(s)
Evaluation
Intervention Description
To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.
Primary Outcome Measure Information:
Title
Inguinal Hernia Mesh Insertion Times
Description
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.
Time Frame
During the procedure an average of an hour
Secondary Outcome Measure Information:
Title
NASA TLX Survey Index Scores
Description
Following surgery, the Hart and Staveland's NASA Task Load Index (TLX) survey was completed by the surgeon to evaluate the surgeon's perceived difficulty and success of the operation. Scale ranges from very low (0) to very high (20) on a 20 point scale (0-20 points). For all outcome measures except performance, 0 indicates the worst outcome and 20 indicates the best outcome. For performance, 0 indicates perfect and 20 indicates failure.
Time Frame
During procedure an average of 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William W Hope, MD
Organizational Affiliation
South East Area Health Education Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32232645
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.
Results Reference
derived

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Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

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