The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair
NCT01596049 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 7
Last updated 2017-08-22
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).
Conditions
- Primary Inguinal Hernia
- Unilateral Hernia
- Open Surgery
Interventions
- DEVICE
-
Self-fixating Mesh
Using Self-fixating Mesh for Inguinal Hernia Repair
Sponsors & Collaborators
-
Rambam Health Care Campus
lead OTHER
Principal Investigators
-
Adel Abu_Salih, M.D · Rambam health care campus, Haifa, Israel
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2017-08-31
- Completion
- 2017-08-31
Countries
- Israel
Study Locations
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