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临床试验/NCT00962338
NCT00962338已完成不适用

Pain and Convalescence After Laparoscopic Groin Hernia Repair

Zealand University Hospital1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
210
试验地点
1
主要终点
duration of convalescence

研究概览

简要总结

The investigators want to identify limiting factors for short convalescence after laparoscopic groin hernia repair. Before the operation patients are given intensive structured information about one day´s convalescence. Patients fill out questionnaire before operation about several clinically relevant parameters. This is also done first 3 days after operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and 6 months.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • planned laparoscopic inguinal or femoral herniorrhaphy
  • ASA class I-II
  • speak and read danish

排除标准

  • converting to open operation
  • low compliance (dementia, psychiatric disorder)
  • use of morphine or similar drugs daily in the last month
  • complications to the operation

结局指标

主要结局

duration of convalescence

时间窗: 3 weeks in average

次要结局

  • fatigue scores on numeric rating scale (1-10)(6 months)
  • Pain scores on visual analog scale and verbal rating scale(6 months)
  • nausea scores on verbal rating scale(3 days)
  • Pain catastrophizing scale (PCS)(Baseline (before operation))
  • sexual dysfunction(6 months)
  • vomiting(3 days)
  • wellbeing scores on visual analog scale(6 months)
  • Activity assessment scale (AAS)(Baseline (before operation))
  • Hospital anxiety and depression scale (HAD)(Baseline (before operation))

研究者

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

Mette Astrup Madsen

M.D.

Zealand University Hospital

研究点 (1)

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