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临床试验/NCT01329120
NCT01329120Unknown不适用

Short and Long-term Effects of Surgical Repair of Pectus Excavatum and Pectus Carinatum - A Questionnaire Study of Persistent Post-surgical Pain, Health-related Quality of Life, Patient Satisfaction, and Aesthetic Outcome

University of Aarhus1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Persistent post-surgical pain

研究概览

简要总结

A large number of institutions have reported their early results with minimally invasive repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed the outcomes relevant to the concerns of the patients and even fewer have reported long-term results following bar removal. Even fewer studies have investigated the prevalence and characteristics of long term persistent post-surgical pain following surgical repair of pectus deformities. The reasons as to why acute postoperative pain in some patients persists and becomes chronic whereas in others the pain dies down shortly after wound healing are largely unknown, and why some patients complain of loss of sensibility in wide regions of their chest following surgery also remains unclear.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Minimally invasive repair of pectus excavatum from 2001 throughout
  • Open surgical repair of pectus carinatum from 2001 throughout 2010.

排除标准

  • Not being able to fill in detailed questionnaires in Danish

结局指标

主要结局

Persistent post-surgical pain

时间窗: At least 4 months following surgery

Persistent post-surgical pain is in this study defined as pain developing after pectus surgery and lasting for at least 4 months. Other causes of pain (e.g. infection and malignancy) and pain continuing from a pre-existing pain problem will be excluded. Persistent post-surgical pain present at time of the study will be assessed by means of a specifically developed questionnaire including items from the Danish translation of the Brief Pain inventory (BPI-short form) and the Danish translation of the short version of the McGill Pain Questionnaire (SF-MPQ).

次要结局

  • Patient satisfaction(At least 4 months following surgery)
  • Health related quality of life(At least 4 months following surgery)
  • Aesthetic outcome(At least 4 months following surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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