Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a single-center, prospective, randomized controlled trial designed to compare clinical outcomes between self-gripping mesh and conventional mesh with limited tacker fixation in laparoscopic totally extraperitoneal (TEP) inguinal hernia repair.
Adult patients diagnosed with inguinal hernia and scheduled for laparoscopic TEP repair are randomly assigned to receive either a self-gripping mesh (Progrip™) or a conventional mesh fixed with a single permanent tacker to the pubic bone (Parietex™). Both meshes are commonly used in clinical practice and approved for inguinal hernia repair.
The primary objective of this study is to evaluate postoperative discomfort and quality of life following surgery. Outcomes are assessed using validated patient-reported questionnaires, including the Carolina Comfort Scale (CCS) and the International Prostate Symptom Score (IPSS). Secondary outcomes include postoperative complications, physical examination findings such as local induration or tenderness, operative time, and short-term hernia recurrence.
Patients are followed at 1 week, 3 weeks, and 3 months after surgery. The results of this study aim to provide comparative evidence regarding the safety and short-term clinical outcomes of self-gripping versus tacker-fixed conventional mesh in laparoscopic TEP inguinal hernia repair.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-gripping mesh (Progrip™) | Experimental | Participants assigned to this arm undergo laparoscopic totally extraperitoneal (TEP) inguinal hernia repair using a self-gripping mesh (Progrip™). The mesh is positioned in the preperitoneal space without the use of additional fixation devices, relying on its microgrip technology for adherence. All other aspects of the surgical procedure are standardized. |
|
| Conventional mesh with tacker fixation (Parietex™) | Active Comparator | Participants assigned to this arm undergo laparoscopic totally extraperitoneal (TEP) inguinal hernia repair using a conventional mesh (Parietex™). The mesh is fixed with a single permanent tacker placed on the pubic bone to ensure mesh stability. No fixation is applied to muscle or nerve-bearing areas. All other aspects of the surgical procedure are standardized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-gripping mesh (Progrip™) | Device | self-gripping surgical mesh used during laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. The mesh adheres to surrounding tissue via resorbable microgrips and does not require additional fixation devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative discomfort assessed by the Carolina Comfort Scale (CCS) | Postoperative discomfort and quality of life are assessed using the Carolina Comfort Scale (CCS), a validated hernia-specific questionnaire evaluating pain, mesh sensation, and limitation of movement during daily activities. | From baseline to 1 week and 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative urinary symptoms assessed by the International Prostate Symptom Score (IPSS) | Lower urinary tract symptoms are evaluated using the International Prostate Symptom Score (IPSS), a validated patient-reported questionnaire. | From baseline to 1 week and 3 months after surgery |
| Incidence of postoperative complications |
Not provided
Inclusion Criteria:
Adults aged 19 to 100 years Diagnosed with inguinal hernia Scheduled to undergo laparoscopic totally extraperitoneal (TEP) inguinal hernia repair Able to understand the study procedures and provide written informed consent
Exclusion Criteria:
Patients receiving immunosuppressive therapy or with immune-related diseases Patients with urological conditions requiring urinary catheterization preoperatively or intraoperatively Patients with complicated inguinal hernia, including irreducible hernia or hernia associated with bowel injury Patients with unintended intraoperative injury during surgery Pregnant women or women of childbearing potential without confirmed non-pregnant status Patients who decline to participate or withdraw informed consent
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional mesh with tacker fixation (Parietex™) | Device | A conventional surgical mesh used during laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. The mesh is fixed with a single permanent tacker placed on the pubic bone to ensure mesh stability. |
|
Postoperative complications including seroma, hematoma, urinary retention, wound-related complications, and hernia recurrence are recorded. |
| Up to 3 months after surgery |
| Postoperative physical examination findings | Physical examination findings such as local induration, tenderness, and abdominal wall stiffness at the surgical site are assessed during follow-up visits. | 1 week and 3 months after surgery |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided