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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01638221
• Other study ID #: ME10 0006
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2012
• Last updated: July 31, 2012
• Start date: July 2012

Study information

• Verified date: July 2012
• Source: Genesys Regional Medical Center
• Contact: Adam P Pentel, DO
• Phone: 402-720-5871
• Email: apentel[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
United States	GenesysRMC	Grand Blanc	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Genesys Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	Subjective pain scale rating post surgical	1 year	No
Secondary	return to activities of daily living	returning to their presurgical lifestyle	1 year	No