Inguinal HerniasNCT07350187
Prospective, Randomized, Controlled Trial Comparing Self-Gripping and Conventional Mesh in Laparoscopic Totally Extra Peritoneal Inguinal Hernia Repair
A study testing Self-gripping mesh (Progrip™) and Conventional mesh with tacker fixation (Parietex™) in people with Inguinal Hernias, run by Chungnam National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Inguinal Hernias
- What is being tested?
- Self-gripping mesh (Progrip™) and Conventional mesh with tacker fixation (Parietex™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2024to 14 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Inguinal Hernias
- Being tested
- Self-gripping mesh (Progrip™), Conventional mesh with tacker fixation (Parietex™)
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Self-gripping mesh (Progrip™) |
| 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. Receives: Device: Conventional mesh with tacker fixation (Parietex™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 1 week and 3 months after surgery
Secondary outcomes (3)
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.
Measured: From baseline to 1 week and 3 months after surgery
Incidence of postoperative complications
Postoperative complications including seroma, hematoma, urinary retention, wound-related complications, and hernia recurrence are recorded.
Measured: 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.
Measured: 1 week and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start22 Oct 2024
- Primary completion14 Oct 2025
- Study completion14 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350187
- Sponsor's protocol ID
- TEP001
- Status last verified
- Oct 2024
- First submitted
- 16 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Trial Comparing Self-Gripping and Conventional Mesh in Laparoscopic Totally Extra Peritoneal Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT07350187
- Acronym / sponsor ID
- TEP001
- Conditions
- Inguinal Hernias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 14 Oct 2025 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-gripping mesh (Progrip™) | Experimental | Device: Self-gripping mesh (Progrip™)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 | Device: Conventional mesh with tacker fixation (Parietex™)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. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-gripping mesh (Progrip™)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. | Device | Self-gripping mesh (Progrip™) |
| Conventional mesh with tacker fixation (Parietex™)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. | Device | Conventional mesh with tacker fixation (Parietex™) |
Primary outcome
Postoperative discomfort assessed by the Carolina Comfort Scale (CCS)
Time frame: From baseline to 1 week and 3 months after surgery
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.
3 secondary outcomes
Postoperative urinary symptoms assessed by the International Prostate Symptom Score (IPSS)
Time frame: From baseline to 1 week and 3 months after surgery
Incidence of postoperative complications
Time frame: Up to 3 months after surgery
Postoperative physical examination findings
Time frame: 1 week and 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-gripping mesh (Progrip™) and Conventional mesh with tacker fixation (Parietex™) in people with Inguinal Hernias, run by Chungnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative discomfort assessed by the Carolina Comfort Scale (CCS) (time frame: From baseline to 1 week and 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.