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临床试验/NCT04328597
NCT04328597Unknown不适用

Portuguese Inguinal Hernia Cohort Study

Portuguese Surgical Research Collaborative1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年10月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Chronic postoperative pain

研究概览

简要总结

Prospective national cohort study of patients submitted to elective inguinal hernia repair. The primary outcome is the prevalence of chronic postoperative inguinal pain, according to the EuraHS QoL questionnaire at 3 months postoperatively. The study will be delivered in all Portuguese regions through a collaborative research network. Four 2-week inclusion periods will be open for recruitment. A site-specific questionnaire will capture procedure volume and logistical facilities for hernia surgery.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Elective inguinal hernia repair in a portuguese hospital
  • Willing and able to consent and comply with the follow up protocol

排除标准

  • Urgent/emergent inguinal hernia repair

结局指标

主要结局

Chronic postoperative pain

时间窗: 3 months postoperatively

Score of 3 or above on the pain domains of the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS QoL) assessment, with higher scores indicating higher pain

次要结局

  • Proportion of patients receiving antibiotic prophylaxis before inguinal hernia repair(Intraoperatively)
  • Proportion of patients operated as day case surgery(30 days after surgery)
  • Postoperative morbidity(30 days after surgery)

研究者

发起方
Portuguese Surgical Research Collaborative
申办方类型
Network
责任方
Sponsor

研究点 (1)

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