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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Genesys Regional Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Adam Pentel, Genesys Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01638221
First received: July 9, 2012
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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


Condition
Inguinal Hernia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by Genesys Regional Medical Center:

Primary Outcome Measures:
  • pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Subjective pain scale rating post surgical


Secondary Outcome Measures:
  • return to activities of daily living [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    returning to their presurgical lifestyle


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638221

Contacts
Contact: Adam P Pentel, DO 402-720-5871 apentel@hotmail.com

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

No publications provided

Responsible Party: Adam Pentel, DO, general surgery resident, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT01638221     History of Changes
Other Study ID Numbers: ME10 0006
Study First Received: July 9, 2012
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014