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临床试验/NCT00938210
NCT00938210已完成不适用

Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery

Aarhus University Hospital4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
4
主要终点
Fatigue

研究概览

简要总结

The standard procedure for treating colonic cancer is changing from open surgery to laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass and have a reduction in physical function, but the investigators do not know if this is also the case following laparoscopic surgery.

This study examines how fatigue, quality of life, physical function, and body composition changes following laparoscopic colonic surgery.

Patients are examined preoperatively and postoperative day 10 and 30.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • elective colonic cancer surgery
  • hemicolectomy or sigmoid resection
  • informed consent

排除标准

  • disseminated cancer
  • contraindications for laparoscopic surgery
  • dementia or serious psychiatric disease
  • diseases or other aspects that prohibit participation

结局指标

主要结局

Fatigue

时间窗: Preoperative to postoperative day 10

次要结局

  • Muscular strength(From preoperatively to postoperative day 10 and 30)
  • Change in work capacity (pulse rate)(From pre- to postoperative day 10 and 30)
  • Balance (sway)(From preoperatively to postoperative day 10 and 30)
  • Pain at rest and when moving(From preoperatively to postoperative day 10 and 30)
  • Quality of life (Short Form 36 - SF-36)(From preoperatively to postoperative day 10 and 30)
  • Body weight(From preoperatively to postoperative day 30)
  • Body composition (fat mass and fat free mass estimated by bio-impedance)(From preoperatively to postoperative day 10 and 30)
  • Social support(From preoperatively to postoperative day 10 and 30)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Bach Jensen

Associate Professor, Institute of Public Health Aarhus

Aarhus University Hospital

研究点 (4)

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