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NCT Number: NCT07350187

Prospective, Randomized, Controlled Trial Comparing Self-Gripping and Conventional Mesh in Laparoscopic Totally Extra Peritoneal Inguinal Hernia Repair

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.

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Key information

Conditions

Inguinal Hernias Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chungnam National University Hospital

Daejeon, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative urinary symptoms assessed by the International Prostate Symptom Score (IPSS)

    Time frame: From baseline to 1 week and 3 months after surgery

    Lower urinary tract symptoms are evaluated using the International Prostate Symptom Score (IPSS), a validated patient-reported questionnaire.

  2. Incidence of postoperative complications

    Time frame: Up to 3 months after surgery

    Postoperative complications including seroma, hematoma, urinary retention, wound-related complications, and hernia recurrence are recorded.

  3. Postoperative physical examination findings

    Time frame: 1 week and 3 months after surgery

    Physical examination findings such as local induration, tenderness, and abdominal wall stiffness at the surgical site are assessed during follow-up visits.

Sponsors and collaborators

Lead sponsor

Chungnam National University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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