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临床试验/NCT07350187
NCT07350187已完成不适用

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

Chungnam National University Hospital0 个研究点目标入组 95 人开始时间: 2024年10月22日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
95

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
19 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

申办方类型
Other
责任方
Sponsor

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