Complications Associated With Primary Placement of Radiologically-Inserted Gastrostomy Versus Percutaneous Endoscopic Gastrostomy for Feeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in pain with gastrostomy-tube placement, comparing RIG with PEG
研究概览
简要总结
The purpose of the study is to compare pain, complications, and quality of life after gastrostomy tube is placed by either percutaneous endoscopic gastrostomy (PEG) or radiologically-inserted gastrostomy (RIG) method.
详细描述
Objectives:
Primary objectives: to assess 1) pain and 2) major and minor complications with gastrostomy-tube placement, comparing RIG with PEG
Secondary objectives:
- To compare costs associated with each technique
- To compare anesthesia type used with each technique
- To assess patient quality of life before and after the procedure
Co-primary outcome measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants are randomized to receive either RIG or PEG. Investigator and Outcomes Assessors are masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in pain with gastrostomy-tube placement, comparing RIG with PEG
时间窗: Before the procedure, within 24 hours after procedure, at 48-96 hours after procedure, and at 6 weeks after procedure
Trajectory of the average pain score over time (question 3, Cleeland Brief Pain Inventory), which rates average pain in the past 24 hours, with 0 being no pain and 10 being pain as bad as can be imagined
Minor complications with gastrostomy-tube placement, comparing RIG with PEG
时间窗: At 9 months, if tube still in place
Assessment of the following complications after procedure: Tube occluded, Tube malpositioned/fell out, Tube damaged, Skin erosion, Site redness, Site nodules/induration, Site exudate
Major and minor complications with gastrostomy-tube placement, comparing RIG with PEG
时间窗: At 6 weeks after procedure
Assessment of the following major complications after procedure: Peritonitis, Abscess, Major bleeding requiring intervention and/or transfusion, Bowel perforation, Death; Assessment of the following minor complications after procedure: Minor bleeding, not requiring transfusion, Tube occluded, Tube malpositioned/fell out,Tube damaged, Skin erosion, Site redness, Site nodules/induration, Site exudate
次要结局
- Anesthesia type associated with gastrostomy tube placement, comparing RIG with PEG(Immediately after procedure completion)
- Costs associated with gastrostomy tube placement, comparing RIG with PEG(Immediately after procedure completion)
- Patient quality of life associated with gastrostomy tube placement, comparing RIG with PEG, before and after the procedure(At 6 weeks after procedure)
研究者
Melissa J. Neisen
Principal Investigator
Mayo Clinic