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

NCT ID: NCT01638221

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Inguinal Hernia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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heavy weight mesh

Surgipro mesh is a heavier weighted mesh with less flexibility after surgery

No interventions assigned to this group

light weight mesh

UltraPro mesh is a lighter weighted mesh with theoretically less stiffness and more flexibility compared to heavier weighted meshes

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ascension Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Adam Pentel

DO, general surgery resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam P Pentel, DO

Role: PRINCIPAL_INVESTIGATOR

Ascension Health

Locations

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GenesysRMC

Grand Blanc, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam P Pentel, DO

Role: CONTACT

Phone: 402-720-5871

Email: [email protected]

Other Identifiers

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ME10 0006

Identifier Type: -

Identifier Source: org_study_id