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| Name | Class |
|---|---|
| Fund for Scientific Research, Flanders, Belgium | OTHER |
| Agentschap voor Innovatie door Wetenschap en Technologie | OTHER |
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A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lightweight TiMesh | Experimental |
| |
| lightweight VyproII | Experimental |
| |
| Heavyweight Marlex | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic (TEP) inguinal hernia repair | Procedure | laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group) |
| Measure | Description | Time Frame |
|---|---|---|
| Male fertility aspects | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life, pain development, recurrence | 1, 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Miserez, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20622657 | Derived | Peeters E, Spiessens C, Oyen R, De Wever L, Vanderschueren D, Penninckx F, Miserez M. Laparoscopic inguinal hernia repair in men with lightweight meshes may significantly impair sperm motility: a randomized controlled trial. Ann Surg. 2010 Aug;252(2):240-6. doi: 10.1097/SLA.0b013e3181e8fac5. |
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| lightweight TiMesh | Device |
|
| lightweight VyproII | Device |
|
| Heavyweight Marlex | Device |
|
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| C072829 | tetraethylpyrazine |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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