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临床试验/NCT01638221
NCT01638221Unknown不适用

Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair

Ascension Health1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
pain

研究概览

简要总结

This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.

详细描述

This is a clinical trial comparing standard therapy in the use of either lightweight or heavy mesh for the repair of inguinal hernias. Both types of these meshes have been approved for surgical correction but subjective comparisons of patient overall satisfaction and perceived outcomes have not been measured. The investigators intend to measure certain subjective data in the form of a questionnaire will be issued to the patient preoperatively, one week, one month, six months, and one year after the surgery There is no recent literature comparing subjective data between two meshes called Ultra Pro and Surgi Pro. The biological effects of these meshes have identical properties as far as the healing process and inflammation as well as the low rate of infection. The main difference is the material that these meshes are composed of. The Ultra Pro is made of Prolene while the Surgi Pro is made of polypropylene.

The risks are not increased anymore than that for normal surgical complications. They each have the same post operative risks including bleeding, infection and pain, but the investigators are investigating a possible subjective difference between these two separate meshes that are currently used.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • over the age of 18
  • unilateral side to be repaired
  • no major abdominal surgery previously

排除标准

  • under age 18
  • bilateral repairs undertaken

结局指标

主要结局

pain

时间窗: 1 year

Subjective pain scale rating post surgical

次要结局

  • return to activities of daily living(1 year)

研究者

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

Adam Pentel

DO, general surgery resident

Ascension Health

研究点 (1)

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