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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01638221
Recruitment Status : Unknown
Verified July 2012 by Adam Pentel, Genesys Regional Medical Center.
Recruitment status was:  Recruiting
First Posted : July 11, 2012
Last Update Posted : August 1, 2012
Information provided by (Responsible Party):
Adam Pentel, Genesys Regional Medical Center

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

Condition or disease
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
Estimated Enrollment : 200 participants
Time Perspective: Prospective
Official Title: Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

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

Primary Outcome Measures :
  1. pain [ Time Frame: 1 year ]
    Subjective pain scale rating post surgical

Secondary Outcome Measures :
  1. return to activities of daily living [ Time Frame: 1 year ]
    returning to their presurgical lifestyle

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients over the age of 18 who are undergoing a unilateral repair of inguinal hernias laparoscopically

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01638221

Contact: Adam P Pentel, DO 402-720-5871

United States, Michigan
GenesysRMC Recruiting
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Genesys Regional Medical Center
Principal Investigator: Adam P Pentel, DO Genesys Regional Medical Center

Responsible Party: Adam Pentel, DO, general surgery resident, Genesys Regional Medical Center Identifier: NCT01638221     History of Changes
Other Study ID Numbers: ME10 0006
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal