跳至主要内容
临床试验/NCT05091853
NCT05091853已完成不适用

Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2021年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
174
试验地点
1
主要终点
Pain during the first post-operative week

研究概览

简要总结

Self-fixed mesh and postoperative pain after laparoscopic inguinal hernia surgery, a randomized clinical trial

详细描述

Pain after inguinal hernia surgery is a major problem for the patient and results in lower quality of life. In this randomized clinical trial we examine if the choice of self-fixed mesh affects post-operative inguinal pain in laparoscopic hernia surgery. 164 patients are randomized and followed up for 1 year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with a clinical inguinal hernia, who are operated with laparoscopic surgery in day case surgery

排除标准

  • scrotal or incarcerated hernia
  • previous laparotomy
  • BMI <18 or >35
  • Liver cirrhosis
  • No hernia in clinical examination

研究组 & 干预措施

Self-adhesive mesh

Active Comparator

干预措施: Adhesix mesh (Device)

Self-gripping mesh

Active Comparator

干预措施: Adhesix mesh (Device)

结局指标

主要结局

Pain during the first post-operative week

时间窗: 1 year

The degree of pain (VAS score) and the use of pain medication during the first postoperative week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna-Maria Thölix

MD

Helsinki University Central Hospital

研究点 (1)

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