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临床试验/NCT01391455
NCT01391455Unknown不适用

Isolation of the Spermatic Cord Following Mesh Inguinal Hernia Repair

Chatham Kent Health Alliance1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
220
试验地点
1
主要终点
Evaluation of groin or testicular pain lasting longer than 3 months postoperatively.

研究概览

简要总结

There are in excess of 1 million operations performed annually to repair inguinal hernias, mostly in the male population. Unfortunately, some patients continue to suffer both groin or testicular pain for varying lengths of time postoperatively. This can lead to a severe degradation of the patient's lifestyle, work habits and sexual function. The origin of the pain is felt to be secondary to the inflammatory reaction caused by the mesh. This also involves the spermatic cord and its structures, leading to orchidinia and possibly azospermia.

详细描述

In this prospective randomized trial, male patients with a primary symptomatic unilateral inguinal hernia will be admitted to the trial. All patients must be over 21 years of age. In order to avoid inguinal nerve entrapment or damage by mesh fixation sutures Covidien Parietene ProGrip mesh will be employed. This mesh does not require fixation. Standard open inguinal hernia repair will take place with nerve preservation, as day surgery cases. In the randomized portion of the study, the mesh will be placed as usual along the posterior wall of the inguinal canal, however the inguinal ligament will be interposed between the mesh and the spermatic cord, thus isolating the cord from intimate contact with the mesh, and a reduction in postoperative inflammatory changes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Clinical diagnosis of a primary unilateral inguinal hernia

排除标准

  • Medically unfit for surgical repair

结局指标

主要结局

Evaluation of groin or testicular pain lasting longer than 3 months postoperatively.

时间窗: 1 year postoperatively

All patients will be evaluated using the Carolina's Comfort Scale

次要结局

  • Number of patients with adverse events.(1 year)

研究者

申办方类型
Other

研究点 (1)

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