Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair

This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.

Study Overview

• Status: Unknown
• Conditions: Inguinal Hernia

Detailed Description

This is a clinical trial comparing standard therapy in the use of either lightweight or heavy mesh for the repair of inguinal hernias. Both types of these meshes have been approved for surgical correction but subjective comparisons of patient overall satisfaction and perceived outcomes have not been measured. The investigators intend to measure certain subjective data in the form of a questionnaire will be issued to the patient preoperatively, one week, one month, six months, and one year after the surgery There is no recent literature comparing subjective data between two meshes called Ultra Pro and Surgi Pro. The biological effects of these meshes have identical properties as far as the healing process and inflammation as well as the low rate of infection. The main difference is the material that these meshes are composed of. The Ultra Pro is made of Prolene while the Surgi Pro is made of polypropylene.

The risks are not increased anymore than that for normal surgical complications. They each have the same post operative risks including bleeding, infection and pain, but the investigators are investigating a possible subjective difference between these two separate meshes that are currently used.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Recruiting
      • GenesysRMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients over the age of 18 who are undergoing a unilateral repair of inguinal hernias laparoscopically

Description

Inclusion Criteria:

• over the age of 18
• unilateral side to be repaired
• no major abdominal surgery previously

Exclusion Criteria:

• under age 18
• bilateral repairs undertaken

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
heavy weight mesh; Surgipro mesh is a heavier weighted mesh with less flexibility after surgery
light weight mesh; UltraPro mesh is a lighter weighted mesh with theoretically less stiffness and more flexibility compared to heavier weighted meshes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	Subjective pain scale rating post surgical	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
return to activities of daily living	returning to their presurgical lifestyle	1 year

Collaborators and Investigators

• Sponsor: Ascension Genesys Hospital
• Investigators: Principal Investigator: Adam P Pentel, DO, Ascension Genesys Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Estimate): August 1, 2012
• Last Update Submitted That Met QC Criteria: July 31, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: ME10 0006