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

A

Ascension Health

Status

Unknown

Conditions

Inguinal Hernia

Study type

Observational

Funder types

Industry

Identifiers

NCT01638221
ME10 0006

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

heavy weight mesh
Description:
Surgipro mesh is a heavier weighted mesh with less flexibility after surgery
light weight mesh
Description:
UltraPro mesh is a lighter weighted mesh with theoretically less stiffness and more flexibility compared to heavier weighted meshes

Trial contacts and locations

1

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Central trial contact

Adam P Pentel, DO

Data sourced from clinicaltrials.gov

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