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recruitment was not going well.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-fixating Mesh | patients attributed to that arm, undergoing surgery of open inguinal unilateral hernia repair, using Self-fixating Mesh which is acceptable in the literature. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-fixating Mesh | Device | Using Self-fixating Mesh for Inguinal Hernia Repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of post operative inguinal Hernia recurrence. | 2 weeks, 3,6,12,24 months post-operative | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients who are undergoing Inguinal Hernia Repair Surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Adel Abu_Salih, M.D | Rambam health care campus, Haifa, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
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