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临床试验/NCT01476241
NCT01476241已完成不适用

Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist: a Single Institution Experience

University of Helsinki1 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2005年9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
292
试验地点
1
主要终点
Complications and mortality

研究概览

简要总结

The investigators main endpoint was focused on the analysis of the type, rate and the impact of different clinical parameters on the complications of the PEG tube placements performed at the Department of Otorhinolaryngology - Head and Neck Surgery since October 2008. In addition, the investigators aimed to compare the results with a historic cohort patient group (September 2005 - October 2008) sent to the Department of Surgery for PEG tube placement in order to evaluate the results of the changed routine.

详细描述

We retrospectively reviewed a cohort of patients that had undergone PEG tube placement from October 2008 until October 2010 at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Central Hospital (HUCH), Helsinki, Finland, with a health care district currently including approximately 1.5 million inhabitants. Hospital surgical and discharge registries were used to identify the patients. Medical records were studied and details collected on the patients' age, sex, preoperative condition, preoperative laboratory parameters, coexisting medical diagnoses (Charlson Comorbidity Index, CCI (Hall 2004)), indication and date for PEG tube placement, complications, the time of PEG use, follow-up time, and clinical status at last follow up. The study period was aimed to run from PEG tube placement to the last clinical evaluation (minimum 12 months) or the time of death. These results were compared with those from a historic cohort group of patients with the PEG tube placed in the Department of Surgery, HUCH, Helsinki, Finland from September 2005 until October 2008.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ENT patient with PEG tube placement

排除标准

  • electrolyte imbalance
  • coagulation imbalance
  • morbid obesity (BMI > 40 kg/m2)
  • large volume ascites
  • previous gastrectomy

结局指标

主要结局

Complications and mortality

时间窗: 12 months follow-up time

Complication * Minor * Major Mortality * Procedure related * \< 7 days * 7-30 days * 30 days * Overall

次要结局

未报告次要终点

研究者

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

Leif Back

Dr

University of Helsinki

研究点 (1)

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