Open Surgery, Primary Inguinal Hernia, Unilateral Hernia
Conditions
Brief 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.
Interventions
DEVICESelf-fixating Mesh
Using Self-fixating Mesh for Inguinal Hernia Repair
Sponsors
Rambam Health Care Campus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing primary unilateral open Inguinal Hernia Repair . * patients undergoing elective surgery. * above the age of 18 years old
Exclusion criteria
* patients having repeated Inguinal Hernia. * patients having bilateral Hernia. * patients undergoing laparoscopic surgery. * patients undergoing non-elective surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative patient quality of life will be assessed using a validated questionnaire. | 2 weeks, 3,6,12,24 months post-operative |
| Pain will be assessed by NRS (Numerical Rating Scale) | 2 weeks, 3,6,12,24 months post-operative |
| Post-operative complications will be assessed using a validated questionnaire. | 2 weeks, 3,6,12,24 months post-operative |
| Percentage of post operative inguinal Hernia recurrence. | 2 weeks, 3,6,12,24 months post-operative |
Countries
Israel
Outcome results
None listed