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临床试验/NCT02305082
NCT02305082已完成不适用

Fast-track Giant Ventral Hernia Repair

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年12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
32
试验地点
1
主要终点
Time to discharge

研究概览

简要总结

The implementation of an enhanced recovery pathway after giant ventral hernia repair, including preoperative high-dose steroid is examined prospectively and compared with a group of historic controls.

详细描述

All patients operated on for a large incisional hernia are treated according to the study protocol. Patients are given high-dose glucocorticoid preoperative and the aim is to discharge patients at postoperative day 3.

Morbidity, length of stay, pain, nausea and pulmonary function are among registered outcomes compared with a historic control group.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Horizontal fascia defect > 10 cm on computed tomography scan
  • Planned elective open incisional hernia repair

排除标准

  • Known allergy against glucocorticoid treatment
  • Insulin-treated diabetes
  • Gastric ulcer diagnosed within four weeks preoperative
  • Steroid-treated immune disease
  • Planned intestinal anastomosis concomitant to hernia repair

结局指标

主要结局

Time to discharge

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 72 hours

Time from surgery to discharge \[Hours\].

次要结局

  • Fatigue(Preoperative and for the duration of hospital stay, an expected average of 3 days)
  • Pain from supine to standing(Preoperative and for the duration of hospital stay, an expected average of 3 days)
  • C-reactive protein from venous blood sample(Preoperative and for the duration of hospital stay, an expected average of 3 days)
  • Pain when walking 6 meters(Preoperative and for the duration of hospital stay, an expected average of 3 days)
  • Vomiting episodes(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
  • Continuous transcutaneous saturation(From surgery to postoperative day 3 at 12 pm)
  • Nausea(Preoperative and for the duration of hospital stay, an expected average of 3 days)
  • Time to bowel function(For the duration of postoperative hospital stay, an expected average of 72 hours)
  • Ear temperature(Preoperative and for the duration of hospital stay, an expected average of 3 days)
  • Detailed reason for not being discharged if criteria are otherwise fulfilled(From surgery and for the duration of hospital stay, an expected average of 3 days)
  • Daily wound drain production(From surgery and for the duration of hospital stay, an expected average of 3 days)

研究者

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

Kristian Kiim Jensen

MD, PHD student

Bispebjerg Hospital

研究点 (1)

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