Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- abdominal pain
研究概览
简要总结
A 12 months mono-center, descriptive study, to evaluate pain and predictive factors Following placement of percutaneous Radiologic gastrostomy (PRG).
The primary objective is to evaluate the abdominal pain associated with percutaneous radiologic gastrostomy (PRG) placement.
详细描述
PRG is a pathway first of all enteral nutrition that has several advantages: local anesthesia, possible in case of esophageal stenosis, Rates of successful tube placement higher for radiologic gastrostomy than for percutaneous endoscopic Gastrostomy (PEG).
Abdominal pain following percutaneous radiologic gastrostomy (PRG) placement is a recognized complication. However, the prevalence and degree of severity of pain are poorly characterized. This pain often requires antalgic treatment.
The primary objective is to evaluate the abdominal pain from Baseline until 7 days after radiologic gastrostomy (PRG) placement.
The secondary objective is to evaluate predictive factors
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Needing a radiologic gastrostomy under local anesthesia
- •Age ≥ 18 years old
- •Read, write and understand the French language
排除标准
- •Patient under guardianship, deprived of liberty, safeguard of justice
- •Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator)
- •Refusal to participate in research
研究组 & 干预措施
single group assignment
only one arm. Each patient complete numerical scale questionnaire (0-10)
结局指标
主要结局
abdominal pain
时间窗: 7 days
numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
predictive factors
时间窗: DAY 1
determine predictive factors of pain suspected in advance: * Fasting anterior stomach wall depth estimated during the ultrasound survey(mm) * Gastric topography determined under X-ray (subcostal / partially retrohepatic) * Topography of the anchors: large tuberosity / antrum * Distance of anchors from each other (mm) * Depth of the anchors (mm) * Skin depression of anchors: (with depression, without depression) * Intraparietal length of the gastrostomy tube (mm)
次要结局
未报告次要终点