NCT01596049

The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair

The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair, in Comparison to the Standard Treatment in the Literature

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia. The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center. The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).

Detailed description

This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia. The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center. The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc). The data will be compared to the literature and will be statistically analysed. The follow-up for each patient will be two years.

Conditions

• Primary Inguinal Hernia
• Unilateral Hernia
• Open Surgery

Interventions

Type	Name	Description
DEVICE	Self-fixating Mesh	Using Self-fixating Mesh for Inguinal Hernia Repair

Timeline

• Start date: 2012-05-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2012-05-10
• Last updated: 2017-08-22

Locations

1 site across 1 country: Israel