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临床试验/NCT04203940
NCT04203940已完成不适用

Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair: A Randomized Controlled Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Pain score at 12 months after surgery

研究概览

简要总结

Because it avoids direct nerve irritation or entrapment, mesh fixation with tissue adhesive glue seems an optimal option to reduce postoperative pain. Indeed, preliminary results published with different glues all showed promising results with reduced postoperative pain.

This randomized controlled study aimed to compare mesh fixation using N-butyl 2-cyanoacrylate with classical suture fixation in Lichtenstein hernia repair in terms of chronic groin pain, postoperative complications, operative time and recurrence.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both genders aging between 18-65 years with primary unilateral uncomplicated inguinal hernia were included.

排除标准

  • Patients with bilateral or sliding inguinal hernia.
  • incarcerated or strangulated hernia
  • recurrent inguinal hernia
  • femoral hernia
  • patients unwilling to participate in the trial.

结局指标

主要结局

Pain score at 12 months after surgery

时间窗: 12 months after hernia repair

Pain assessed by visual pain scale from 0-10

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

Sameh Emile

lecturer of surgery

Mansoura University

研究点 (2)

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